Patent Publication Number: US-2022212004-A1

Title: Transvaginal treatment of stress urinary incontinence

Description:
RELATED APPLICATION DATA 
     This patent application is a continuation of International Patent Application No. PCT/US2020/055948, filed Oct. 16, 2020, which claims priority to U.S. provisional application No. 62/924,380, filed Oct. 22, 2019, entitled “TRANSVAGINAL TREATMENT OF STRESS URINARY INCONTINENCE”, each of which applications is herein incorporated by reference in its entirety. 
    
    
     FIELD 
     The present disclosure relates generally to medical devices and techniques for treating stress urinary incontinence. 
     BACKGROUND 
     Urethral closure pressure must be greater than urinary bladder pressure, both at rest and during increases in abdominal pressure, to retain urine in the bladder. Measurements of urethral closure pressure using intraurethral catheters have shown that, when a patient is supine, the resting pressure in the bladder neck is about 30 cm H2O, and increases to about 80 cm H2O in a healthy patient approximately halfway along the urethra, after which it decreases to atmospheric pressure at the external meatus of the urethra. Urinary incontinence (UI) occurs when the bladder pressure exceeds the maximum urethral closure pressure, and is one of the most prevalent conditions of the lower urinary tract. The most common type of UI is stress urinary incontinence (SUI), which affects a significant number of people, mostly women. During activities, such as coughing, sneezing, laughing, and exercise, when the bladder pressure increases several times higher than resting urethral pressure, a dynamic process should increase the urethral pressure to enhance urethral closure and thereby maintain urinary continence. SUI occurs when this dynamic process fails, and a sudden increase in the intra-abdominal pressure exceeds the urethral pressure, causing the loss of small amounts of urine. 
     Currently, there is a large gap in treatment options for SUI between conservative methods (Kegels) and surgical intervention (slings). 
     Some proposed SUI treatments include the delivery of energy to and/or through the urethral wall by precisely placing an elongated probe having an energy delivery element within the urinary tract, as described in U.S. Pat. No. 9,687,331. These probes can have an anchoring member, such as an inflatable balloon, at a distal portion of the probe that sits in a patient&#39;s bladder, and a locking device at the proximal portion of the probe that is placed against the patient&#39;s external urethral orifice, urinary meatus and/or adjacent tissue, thereby securing the probe and the energy delivery member in a desirable position within the urethra. These SUI treatments require complicated mechanisms for minimizing movement of the probe relative to the desired treatment site in the urethra and/or paraurethral region, as well as, maintaining patency of the probe lumen. Furthermore, such SUI treatments denature the urethral or paraurethral tissue, and thus, are irreversible. 
     Other proposed SUI treatments electrically stimulate the nerves, including the sacral nerve or pudendal nerve, as described in U.S. Pat. Nos. 6,449,512, 6,505,074, 6,735,474, 6,836,684, 6,907,209, 6,941,171, 7,047,078, 7,054,689, 7,177,703, 7,343,202, 7,369,894, 7,565,198, and 8,644,938, or stimulate the bladder itself, as described in U.S. Pat. No. 7,769,460; or directly stimulate the pelvic floor or periurethral muscles, as described in U.S. Pat. Nos. 6,354,991, 6,659,936, and 7,613,516. However, these SUI treatments require invasive implantation of the electrodes, as well as the electrical energy source, within the patient. 
     Still other proposed SUI treatments involve transanally or transvaginally stimulating pelvic floor muscles (e.g., the levator ani) in order to emulate Kegel exercises that strengthen the weakened muscles that were previously thought to cause SUI, as described in U.S. Pat. Nos. 5,370,671 and 6,402,683 due to loss of their supporting function. Stimulation of the pelvic floor muscles, particularly levator ani muscles, is performed in either a clinical setting or home setting using a probe that carries electrodes (e.g., annular electrodes) that non-specifically stimulate the pelvic floor muscles surrounding the vagina or anus. However, in this case, because the electrical stimulation is non-specific, muscles that are not associated with the SUI, in addition to the dysfunctional muscles, are electrically stimulated. Some SUI treatments target only the dysfunctional pelvic floor muscles that cause the SUI by using biofeedback, as described in U.S. Pat. No. 9,656,067. However, these systems require the use of relatively large electrodes and involve a complicated setup. One such system includes an array of electrode patches that extend axially along and circumferentially around a probe to measure electromyography (EMG) signals in the pelvic floor muscles, as well as an external stimulation and control unit, requiring clinical intervention to identify and train the weakened pelvic floor muscles that were thought to cause the SUI. 
     Research, however, indicates that the main factor causing SUI is weak urethral sphincter muscle(s), rather than a loss of support provided by the pelvic floor muscles or the passive tissue beneath the urethra (see John O. L. Delancey, et al., “ Stress Urinary Incontinence: Relative Importance of Urethral Support and Urethral Closure Pressure, ” The Journal of Urology, Vol. 179, 2286-2290, June 2008; John O. L. Delancey, et al., “Differences in Continence System Between Community-Dwelling Black and White Women With and Without Urinary Incontinence in the EPI Study,” American Journal of Obstetrics &amp; Gynecology, 584.e1-584.e2, June 2010). Thus, because levator muscle failure is not a prominent feature of SUI, targeting the pelvic floor muscles for stimulation in order to remedy the loss of support has not been effective. Furthermore, despite the fact that the size and shape of pelvic regions vary greatly between females, prior art electrical stimulation devices designed for the treatment of SUI take a one size fits all solution and, thus, may be completely ineffective for a particular set of females due to an improper fitting between the devices and these females. 
     Hence there is an ongoing need to provide an improved device and technique that non-invasively electrically stimulates the target anatomical regions associated with SUI with minimal clinical intervention. 
     SUMMARY 
     In accordance with the disclosed inventions, a transvaginal stimulation device comprises a probe body sized to fit entirely within a vaginal cavity of a female patient. The probe body has a length extending in a longitudinal direction, a width extending in a lateral direction, and a depth extending perpendicular to the length and width. In one embodiment, the probe body is rigid or semi-rigid, and has a total length having a range of 4 cm-8 cm. In another embodiment, the width of the probe body has a greatest lateral extent that is greater than the depth of the probe body. The probe body has a stimulating side defined by the length and the width of the probe. 
     The transvaginal stimulation device further comprises a pair of electrodes (e.g., a transverse pair of electrodes) disposed on the stimulating side of the probe body and laterally spaced from each other. In one embodiment, the transvaginal stimulation device is free of any electrodes laterally disposed relative to the pair of electrodes. In another embodiment, the probe body has a non-stimulating side opposite the stimulating side of the probe body, in which case, the non-stimulating side of the probe body is free of any electrode. In still another embodiment, the pair of electrodes each have an elongated shape and are disposed parallel to each other, and may respectively have lengths extending along the length of the probe body in a range of about 4 mm-12 mm. 
     In one embodiment, the transvaginal stimulation device further comprises stimulation circuitry contained within the probe body. The stimulation circuity is configured for delivering bipolar electrical stimulation energy between the pair of electrodes. In another embodiment, the transvaginal stimulation device further comprises a user interface disposed on the probe body. The user interface is configured for deactivating the stimulation circuitry. 
     A transvaginal stimulation system may comprise the transvaginal stimulation device set forth above, a clinician programmer configured for wirelessly programming the transvaginal stimulation device, and a patient control configured for wirelessly controlling operation of the transvaginal stimulation device. 
     In accordance with a first aspect of the disclosed inventions, the probe body has a concave region longitudinally extending along the stimulating side of the probe body. In this case, the pair of electrodes disposed on the stimulating side of the probe body and laterally spaced from each other, such that the concave region is disposed between the pair of electrodes. In one embodiment, the concave region is shaped to cradle a urethra carina of the female patient when the probe body is positioned in a vaginal cavity of the female patient. 
     In accordance with another aspect of the disclosed inventions, the pair of electrodes have an edge-to-edge lateral spacing in the range of 5 mm-25 mm. In one embodiment, the pair of electrodes have an edge-to-edge lateral spacing in the range of 10 mm-20 mm. 
     In accordance with yet another aspect of the disclosed inventions, a distal region of the probe body laterally flares outward in a distal direction from a mid-region of the probe body to form a flattened scoop. In one embodiment, the flattened scoop angles away from the stimulating side of the probe body. In another embodiment, a proximal region of the probe body laterally flares outward in a proximal direction from the mid-region to form shoulders. In this case, the mid-region of the probe body may be sized and configured, such that when the probe body is fully disposed in the vaginal cavity, levator ani muscles of the female patient are disposed adjacent to the mid-region between the flattened scoop and the shoulders. 
     In accordance with still another aspect of the disclosed inventions, the transvaginal stimulation device further comprises an extraction element extending proximally from the probe body configured for being grasped to extract the probe body from the vaginal cavity of the female patient. In one embodiment, the extraction mechanism comprises a fingerhold having a proximal surface configured for approximating a pubic bone of the female patient when the probe body is fully disposed in the vaginal cavity of the female patient. 
     In accordance with yet another aspect of the disclosed inventions, the pair of electrodes includes a first electrode having a first flat tissue contacting surface and a second electrode having a second flat tissue contacting surface tissue. In this case, the first tissue contacting surface and the second tissue contacting surface form an angle within the range of 160°-200°, preferably in the range of 170°-190°. In one embodiment, the first tissue contacting surface and the second tissue contacting surface form an angle of 180°. 
     In accordance with a still further aspect of the disclosed inventions, the pair of electrodes are respectively positioned on the probe body, so that when the probe body is positioned in a vaginal cavity of the female patient, bipolar electrical stimulation energy delivered between the pair of electrodes to stimulate at least one muscle of a urethral sphincter (e.g., the mid-urethral striated sphincter muscle) of the female patient without substantially stimulating pelvic floor muscles of the female patient. 
     In accordance with yet another aspect of the disclosed inventions, the transvaginal stimulation device further comprises a pair of linear electrode arrays extending along the length of the probe body. In one embodiment, different subsets of electrodes of the respective pair of electrodes arrays are configured for being selectively activated. The subsets of electrodes may, e.g., comprise different bipolar pairs of electrodes, such as transverse bipolar pairs of electrodes or longitudinal bipolar pairs of electrodes. In another embodiment, the different subsets of electrodes are configured for being cyclically activated one-at-a-time. In still another embodiment, a clinician programmer is configured for determining a stimulation regimen by selectively activating different pairs of electrodes respectively in the linear electrode arrays, and programming the transvaginal stimulation device with the stimulation regimen, such that the transvaginal stimulation device is configured for conveying electrical stimulation energy between the pair of electrodes in accordance with the stimulation regimen. 
     In accordance with still another aspect of the disclosed inventions, a proximal region of the probe body comprises shoulders that laterally taper inward in a proximal direction to form a waist. An axial center of the pair of electrodes may be distally spaced from the waist a distance in the range of 1.5 cm-2.5 cm. In one embodiment, the probe body comprises telescoping proximal and distal probe bodies configured for being axially displaced relative to each other, such that a distance between the pair of electrodes and the waist of the probe body can be varied. In another embodiment, the pair of electrodes is configured for being axially displaced relative to the probe body, such that a distance between the pair of electrodes and the waist of the probe body can be varied. 
     In accordance with yet another aspect of the disclosed inventions, a method for treating stress urinary incontinence in a female patient using the transvaginal stimulation device comprises inserting the intravaginal device into a vaginal cavity of the female patient. If the probe body has a concave region longitudinally extending along the probe body, the method can further comprise cradling a urethra carina of the female patient when the probe body is inserted in the vaginal cavity of the female patient. If the width of the probe body has a greatest lateral extent that is greater than the depth of the probe body, the method may further comprise preventing rotation of the probe body relative to the vaginal cavity of the female patient. If the distal region of the probe body laterally flares outward in a distal direction from a mid-region to form a flattened scoop, and the proximal region of the probe body laterally flares outward in a proximal direction from mid-region to form shoulders, the levator ani muscles of the female patient may be disposed adjacent to the mid-region between the flattened scoop and the shoulders when the probe body is fully disposed in the vaginal cavity. If the flattened scoop angles away from the stimulating side of the probe body, the flattened scoop may conform to a posteriorly angled cranial end of the vaginal cavity of the female patent when the probe body is fully disposed in the vaginal cavity. 
     In one embodiment, the method further comprises positioning the pair of electrodes against an anterior wall of the vagina of the female patient, and conveying stimulation energy between the pair of electrodes to stimulate at least one muscle of a urethral sphincter muscle (e.g., a mid-urethral striated sphincter muscle) of the female patient without substantially stimulating pelvic floor muscles of the female patient. In one method, the stimulation energy is unidirectionally conveyed through an anterior wall of a vagina of the female patient to stimulate the urethral sphincter muscle of the female patient. 
     In one embodiment, the method further comprises measuring a urethral closing pressure of the female patient while applying the stimulation energy to the urethral sphincter muscle of the female patient in accordance with a stimulation regimen, and controlling the stimulation regimen in response to the measured urethral closing pressure. Controlling the stimulation regimen may comprise determining a stimulation regimen by selectively activating different pairs of electrodes arranged in a pair of linear electrode arrays extending along the length of the probe body, and programming the transvaginal stimulation device with the stimulation regimen, such that the transvaginal stimulation device is configured for conveying the electrical stimulation energy between the pair of electrodes in accordance with the optimal stimulation regimen. The method may further comprise cyclically conveying stimulation energy between the different pairs of electrodes one-at-a-time to stimulate at least one muscle of a urethral sphincter muscle of the female patient without substantially stimulating pelvic floor muscles of the female patient. 
     In one embodiment, the method further comprises mechanically fitting the transvaginal stimulation device to the female patient. If the probe body comprises telescoping proximal and distal probe bodies, mechanically fitting the transvaginal stimulation to the female patient may comprise axially displacing the telescoping probe bodies relative to each other to vary a distance between the pair of electrodes and the waist of the probe body. Mechanically fitting the transvaginal stimulation device to the female patient may comprise axially displacing the pair of electrodes relative to the probe body to vary a distance between the pair of electrodes and the waist of the probe body. Mechanically fitting the transvaginal stimulation device to the female patient may comprise inserting a plurality of different intravaginal stimulation devices having different distances between a pair of electrodes into the vaginal cavity of the female patient, and selecting the intravaginal stimulation devices from the plurality of different intravaginal stimulation devices. 
     Optionally, the method may further comprise wirelessly controlling operation of the transvaginal stimulation device via a patient control device. Another optional method further comprises terminating the stimulation energy conveyed between the electrodes by actuating a user interface disposed on the probe body. Another optional method further comprises extracting the probe body from the vaginal cavity of the female patient by grasping an extraction element extending proximally from the probe body. If the extraction mechanism comprises a fingerhold, the method may optionally further comprise approximating the pubic bone of the female patient when the probe body is fully disposed in the vaginal cavity of the female patient. 
     Other and further aspects and features of embodiments of the disclosed inventions will become apparent from the ensuing detailed description in view of the accompanying figures. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The drawings illustrate the design and utility of preferred embodiments of the disclosed inventions, in which similar elements are referred to by common reference numerals. It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention, which is defined only by the appended claims and their equivalents. In addition, an illustrated embodiment of the disclosed inventions needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment of the disclosed inventions is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated. In order to better appreciate how the above-recited and other advantages and objects of the disclosed inventions are obtained, a more particular description of the disclosed inventions briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIGS. 1A and 1B  are anatomical views illustrating the periurethral structural components of a female; 
         FIG. 2  is a block diagram of a stress urinary incontinence (SUI) treatment system constructed in accordance with one embodiment of the disclosed inventions; 
         FIGS. 3A-3C  are anatomical views illustrating the transvaginal stimulation device of  FIGS. 6A-6F  inserted into the vaginal cavity of a female patient; 
         FIG. 4  are timing diagrams illustrating various exemplary electrical pulse trains that can be generated by the transvaginal stimulation device of  FIG. 2 ; 
         FIG. 5  is a block diagram of transvaginal stimulation device used in the SUI treatment system of  FIG. 2 ; 
         FIGS. 6A-6F  are various external views of one embodiment of a transvaginal stimulation device for use in the SUI treatment system of  FIG. 2 ; 
         FIG. 7  is an external view of another embodiment of a transvaginal stimulation device for use in the SUI treatment system of  FIG. 2 ; 
         FIGS. 8A and 8B  are anatomical views illustrating the transvaginal stimulation device of  FIGS. 6A-6F  being stabilized by the levator ani of a female patient; 
         FIGS. 9A-9C  are top views of the transvaginal stimulation device of  FIG. 6E  with different electrode positions; 
         FIGS. 10A and 10B  are profile views of yet another embodiment of a transvaginal stimulation device for use in the SUI treatment system of  FIG. 2 ; 
         FIGS. 11A and 11B  are top views of yet another embodiment of a transvaginal stimulation device for use in the SUI treatment system of  FIG. 2 ; 
         FIG. 12  is a top view of yet another embodiment of a transvaginal stimulation device for use in the SUI treatment system of  FIG. 2 ; 
         FIGS. 13A-13P  are plan views of the linear electrode arrays of the transvaginal stimulation device of  FIG. 12 , wherein electrodes can be selectively activated to stimulate targeted areas of the periurethral structure components; and 
         FIG. 14  is a flow diagram illustrating one method of using the SUI treatment system of  FIG. 2  to treat SUI in a patient. 
     
    
    
     DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS 
     In contrast to the conventional approaches that treat stress urinary incontinence (SUI) in a female patient, particularly those that stimulate the pelvic floor muscles (e.g., the levator ani), the inventors have discovered that specifically stimulating the urethral sphincter muscle of the female patient will cause a greater contraction of the urethral sphincter muscle, and therefore, result in a relatively higher urethral closing pressure. Because the urethral sphincter muscle extends along ⅘ths the length of the urethra, and is surrounded by other muscles, including the pubococcygeal and puborectal portions of the pelvic floor muscles, specifically stimulating the urethral sphincter muscle while avoiding stimulation of other muscles in a female patient, especially during physical activity of the patient, presents unique challenges. The SUI treatment system described herein consistently and robustly stimulates the urethral sphincter muscle of a physically active female patient suffering from SUI. Although the SUI treatment system described herein lends itself well to the treatment of SUI in human female patients, it should be appreciated that the SUI treatment system described herein can be adapted to treat non-human female patients, e.g., older pets. 
     As shown in  FIG. 1A , the periurethral components of a female patient  100  comprise a detrusor smooth muscle at the neck of the bladder  102  and the urethra  104 , itself. The urethra  104  is approximately 4-5 cm long in a female, and is embedded in the connective tissue  125  supporting the anterior wall  122  of the vagina  120 , as shown in  FIG. 1B . The urethra  104  comprises a urethral sphincter  106 , which extends lengthwise along the caudal ⅘ths of the urethra  102  to actively control the flow of urine from the bladder  102 , and a nozzle  108 , which extends lengthwise along the remaining cranial ⅕ th  of the urethra  102  to passively control the flow of urine from the bladder  102 . The urethral sphincter  106  comprises three layers of muscle (an outer circumferential layer of striated muscle  110 , a middle circumferential layer of smooth muscle  112 , and an inner longitudinal layer of smooth muscle  114 ) and a vascular plexus  116  surrounding the urethral lumen  118  (see James A. Ashton-Miller and John O. L. DeLancey, “Functional Anatomy of the Female Pelvic Floor, Ann. N.Y. Acad Sci. 1101: 266-296 (2007)). The circumferential striated muscle  110  is under voluntary control, while the circumferential smooth muscle  112  and longitudinal smooth muscle  114  are under involuntary or autonomic control. It is only the circumferential striated muscle  110  that contributes to the voluntary and reflex closure of the urethra  104  during acute instances that result in increased abdominal pressure (e.g., coughing, sneezing, laughing, etc.). 
     The current dogma is that all of the periurethral structural components listed above, including the circumferential striated muscle  110 , the circumferential smooth muscle  112 , the longitudinal smooth muscle  114 , and the vascular plexus  116 , contribute equally to urethral closure pressure, and thus, are the primary structures preventing the involuntary release of urine from the bladder  102 . As such, all of these periurethral structural components contribute to urinary continence, and when dysfunctional, cause urinary incontinence. Based on this dogma, conventional wisdom dictates that electrical stimulation be conveyed along the entire length of the urethra  104  to ensure that all of the periurethral structural components are trained or reeducated, thereby providing maximum efficacy for the treatment of SUI in a female patient. 
     However, in contrast to this, the inventors have discovered that delivering focused stimulation to the middle region of the urethra  104  containing the circumferential striated muscle  110  achieves comparatively higher urethral closure pressure, and thus, is more desirable than stimulating all of the periurethral structural components along the entire length of the urethra  104  in the patient  100 . The inventors have designed and tested an SUI treatment system  10  that specifically stimulates the circumferential striated muscle  110  (i.e., the mid-urethral striated sphincter muscle) of the female patient  100  in a consistent and robust manner even during physical activity of the female patient  100 . 
     Referring now to  FIG. 2 , one embodiment of the SUI treatment system  10  generally comprises a transvaginal stimulation device  12 , a clinician programmer  14 , a patient controller  16 , and an external charger  18 . 
     As shown in  FIGS. 3A-3C , the transvaginal stimulation device  12  is configured for being introduced into a vaginal cavity  124  of the patient  100 , and for delivering electrical stimulation energy (shown by arrow) only through the anterior wall  122  of the vagina  120  towards the middle region of the urethra  104  to target the mid-urethral striated sphincter muscle  110  of the patient  100 , which has been found to be at least as effective at increasing urethral closure pressure as stimulating the pelvic floor muscles surrounding the vagina  120 , while stimulating far fewer muscles that are not responsible for urinary incontinence. 
     Once the transvaginal stimulation device  12  is inserted into the vaginal cavity  124  of the patient  100 , the clinician programmer  14  can be used to program the transvaginal stimulation device  12  in a clinical setting. While it is contemplated that targeted stimulation of the mid-urethral striated sphincter muscle  110  of the patient  100  by the transvaginal stimulation device  12  will provide a robust means for treating the SUI of the patient  100 , as will be described in further detail below, it may be desirable to perform a fitting session to fine tune or optimize such treatment. For example, different transvaginal stimulation regimens may be applied to the patient  100  by controlling the transvaginal stimulation device  12  via the clinician programmer  14  and, in response to each stimulation regimen, observing biofeedback in the form of a detected urethral closure pressure, which has been shown to be highly correlated to SUI. The stimulation regimen or regimens that result in maximum urethral closure pressure can then be selected. Different stimulation frequencies are known to be required to recruit striated muscle (i.e., 50 Hz) than are required to recruit smooth muscle (13 Hz). The difference in response of the two types of muscle to electrical stimulation of the appropriate frequency can be determined by the time constant of the change in closure pressure, with striated muscle reaching a maximum tetanic contraction in about a fifth of a second, while smooth muscle may take many seconds to reach a maximum contraction. 
     Using the biofeedback as guidance, the clinician can operate the clinician programmer  14  to generate custom stimulation programs (each comprising clinician detailed stimulation parameters) and programming the transvaginal stimulation device  12  with the stimulation programs. For example, four exemplary stimulation programs (e.g., warm-up, endurance, massage, cool down) corresponding to four different electrical pulse trains  20   a - 20   d  are illustrated in  FIG. 4 . The transvaginal stimulation device  12  may be programmed to sequentially step through the different stimulation programs in accordance with a timing protocol, or any one of the stimulation programs may be actuated via the patient controller  16 , as discussed below. 
     In the illustrated embodiment, the clinician programmer  14  takes the form of a laptop computer, although in alternative embodiments, the clinician programmer  14  may take the form of a conventional Smartphone configured with a smartphone application with programming capabilities. The clinician programmer  14  may perform this function by indirectly communicating with the transvaginal stimulation device  12 , through the patient controller  16 , via a bi-directional wireless communications link (e.g., using a short-range infrared (IR) protocol)  22 . Alternatively, the clinician programmer  14  may directly communicate with the transvaginal stimulation device  12  via the bi-directional wireless communications link  24  (e.g., using a short-range radio-frequency (RF) protocol, such as a Bluetooth protocol, although other types of short-range RF protocols, such as a Wi-Fi protocol, can be used). More alternatively, the clinician programmer  14  may communicate with the transvaginal stimulation device  12  via a wired connection. The clinician detailed modulation parameters provided by the clinician programmer  14  may also be used to program the patient controller  16 , so that the stimulation parameters can be subsequently modified by operation of the patient controller  16  in a stand-alone mode (i.e., without the assistance of the clinician programmer  14 ). 
     The patient controller  16  may be used to telemetrically control the transvaginal stimulation device  12  via a bi-directional wireless communications link  26  (e.g., using a short-range RF protocols, such as a Bluetooth protocol, although other types of short-range RF protocols, such as a Wi-Fi protocol, can be used). Alternatively, the patient controller  16  may communicate with the transvaginal stimulation device  12  via a wired connection. In any event, control by the patient controller  16  allows the transvaginal stimulation device  12  to be turned on or off, select one of a plurality of different stimulation programs (corresponding to different electrical pulse trains) previously programmed into the transvaginal stimulation device  12  via the clinician programmer  14 , and to modify other parameters of the electrical stimulation energy (e.g., to adjust the intensity of the electrical stimulation or cause the transvaginal stimulation device  12  to ramp up or ramp down the electrical stimulation). The patient controller  16  can take the form of, e.g., a Smartphone. The patient controller  16  may optionally track patient compliance, send reminders and/or encouragement to the patient, share data with physicians, display remaining time left during a session, and track the patient progress. 
     The external charger  18  is a portable device used to transcutaneously charge the transvaginal stimulation device  12  via an inductive link  28 . The external charger  18  may, e.g., wirelessly charge the transvaginal stimulation device  12  or may use contacts to charge the transvaginal stimulation device  12 . In the latter case, the external charger  18  may take the form of a storage container that completely encloses the transvaginal stimulation device  12  during the charging process. Alternatively, the transvaginal stimulation device  12  may be recharged by plugging the transvaginal stimulation device  12  into a household alternating current (AC) socket. More alternatively, the transvaginal stimulation device  12  may not be recharged at all, but instead contains a replaceable non-rechargeable battery. Once the transvaginal stimulation device  12  has been programmed by the clinician programmer  14 , turned on by the patient controller  16 , and charged by the external charger  18 , the stimulation programs are run locally on the transvaginal stimulation device  12  during a stimulation session, and may thus function as programmed without the patient controller  16 , clinician programmer  14 , and external charger  18  being present. The stimulation sessions may be logged locally on the transvaginal stimulation device  12  and uploaded to the patient controller  16  or clinician programmer  14  when communication has been established over the bi-directional wireless link(s). 
     Referring now to  FIG. 5 , the electrical components of the transvaginal stimulation device  12  will be described. The transvaginal stimulation device  12  generally comprises at least one pair of electrodes  30   a,    30   b  (only one pair of electrodes illustrated in  FIG. 5 ), programmable stimulation circuitry  32 , a microcontroller  34 , memory  36 , a rechargeable power circuitry  38 , and wireless communication circuitry  40 . 
     In the preferred embodiment, the electrodes  30   a,    30   b  are respectively activated as an anode and a cathode, such that electrical stimulation energy is transmitted between the electrodes  30   a,    30   b  in a bipolar manner. Although the electrical stimulation energy may be delivered as monophasic electrical energy (i.e., the pulses are either negative (cathodic) or positive (anodic), it is preferred that the electrical stimulation energy is delivered as multi-phasic electrical energy (e.g., a series of biphasic pulses, with each biphasic pulse including a negative (cathodic) pulse (during a first phase) and a positive (anodic) pulse (during a second phase) to prevent direct current charge transfer through tissue, thereby avoiding electrode degradation and cell trauma. 
     The programmable stimulation circuitry  32  is configured for generating electrical stimulation energy in accordance with a defined pulsed waveform having a specified pulse amplitude, pulse rate, pulse width, and pulse shape. In the preferred embodiment, the stimulation circuitry  32  comprises an integrated analog-to-digital converter (ADC) that constantly measures and adjusts the output voltage to maintain a constant current output, thereby guaranteeing constant output to the electrodes  30   a,    30   b  during and between stimulation sessions. 
     In addition to controlling the operation of the transvaginal stimulation device  12 , the microcontroller  34  programs the stimulation circuitry  32  in accordance with one or more stimulation programs stored in the memory  36 . Each of the stimulation programs stored in memory may comprises a set of stimulation parameters (e.g., pulse amplitude (e.g., in the range of 30-40 mA), pulse rate (e.g., in the range of 20 Hz-60 Hz), pulse width (e.g., in the range of 0.1 ms-0.3 ms, and pulse shape) of the electrical stimulation energy (i.e., the pulse train) output by the stimulation circuitry  32 . In one embodiment, up to four stimulation programs may be stored in the memory, although in other embodiments, more or less than four stimulation programs may be stored in the memory. The memory may also store a timing protocol in the case where the transvaginal stimulation device  12  is programmed to automatically step through the different stimulation programs, as well as log stimulation sessions performed by the transvaginal stimulation device  12 . 
     The rechargeable power circuitry  38  comprises a battery, e.g., lithium-ion or lithium-ion polymer battery, and regulation circuitry (not shown). The battery outputs unregulated voltage to the regulation circuitry, which outputs regulated power to the stimulation circuitry  32 , as well as the other components, of the transvaginal stimulation device  12 . The power circuitry  38  is recharged using rectified AC power (or DC power converted from AC power) via the power circuitry  38 , which comprises an AC coil (not shown). To recharge the power circuitry  38  while the transvaginal stimulation device  14  is disposed in the vaginal cavity  124  of the patient  100 , the transvaginal stimulation device  14  may be placed within the external charger  18 , which generates an AC magnetic field, or alternatively, the external charger  18  is placed against, or otherwise adjacent, to the patient  100  over the transvaginal stimulation device  14 . The AC magnetic field emitted by the external charger  18  induces AC currents in the AC coil of the rechargeable power circuitry  38  over the inductive link  28  (shown in  FIG. 2 ), which rectifies the AC current to produce DC current, which is used to charge the power circuitry  38 . Alternatively, the transvaginal stimulation device  14  may be recharged in a storage container or external charger while not in use. 
     The communication circuitry  40  comprises an antenna (not shown) for receiving programming data (e.g., stimulation programs) from the clinician programmer  14  over the wireless communications link  26  (shown in  FIG. 1 ), which programming data is stored in the memory, and patient control data (e.g., on/off, amplitude control, stimulation program selection) from the patient programmer  14  over the wireless communications link  26 . The communication circuitry  40  may also transmit status information or logged stimulation sessions to the clinician programmer  14  or patient controller  16  over the communications link  26 . 
     Referring to  FIGS. 6A-6F , one embodiment of a transvaginal stimulation device  12  will now be described. Focused stimulation of the mid-urethral striated sphincter muscle  110  presents challenges in that the anatomy of the vaginal cavity  124  and location of the middle region of the urethra  104  relative to the vaginal cavity  124  may vary widely over patients. The transvaginal stimulation device  12  is aptly and robustly capable of treating a wide variety of patients while focusing stimulation energy on the mid-urethral striated sphincter muscle  110  of a patient  100 . 
     The transvaginal stimulation device  12  generally comprises a probe body  42 , an extraction mechanism  44  extending from a proximal region  43  of the probe body  42 , an optional minimal user interface (UI)  46  located on the proximal region  43  of the probe body  42 , and a pair of electrodes  30   a,    30   b  disposed on the probe body  42 . As will be described in further detail below, the transvaginal stimulation device  12  may optionally comprise additional pairs of electrodes. 
     The extraction mechanism  44  is designed to extend outside of the vaginal cavity  124  of the patient  100 , thereby providing a convenient means of extracting the transvaginal stimulation device  12  from the vaginal cavity  124  of the patient  100 , e.g., after a stimulation session has been completed. To this end, the extraction mechanism  44  comprises an elongated tail member  48  affixed to the proximal region  43  of the probe body  42 , and a fingerhold  50  affixed to the elongated tail member  48 . The elongated tail member  48  has a pre-shaped C-geometry, such that the fingerhold  50  is disposed above the stimulating side  52   a  of the probe body  42  in the absence of force. While the transvaginal stimulation device  12  is fully disposed in the vaginal cavity  124  of the patient  100 , a distal facing surface  62  of the fingerhold  50  (shown in  FIG. 6F ) approximates the pubic bone  126  of the patient  100 , without placing undue pressure on the clitoris of the patient  100 , causing the elongated tail member  48  to form an angle with the longitudinal axis of the probe body  42  of approximately 90 degrees, as illustrated in  FIG. 3A . The fingerhold  50  of the extraction mechanism  44  also serves as a visual indicator to ensure that the electrodes  30   a,    30   b  of the transvaginal stimulation device  12  are facing the anterior wall  122  of the vagina  120 . That is, when the fingerhold  50  is in the 12 o&#39;clock position, immediately under the pubic bone  126  of the patient  100 , as illustrated in  FIG. 3C , the patient  100  can visually confirm that the electrodes  30   a,    30   b  of the transvaginal stimulation device  12  are facing the anterior wall  122  of the vagina  120 , and furthermore, that the probe body  42  is not cock-eyed (i.e., the distal tip of the probe body  42  does not veer left, right, or up). In contrast, if the fingerhold  50  is not in the 12 o&#39;clock position, the patient  100  knows that the transvaginal stimulation device  12  must be adjusted to face the electrodes  30   a,    30   b  towards the anterior wall  122  of the vagina  120 . 
     In an optional embodiment illustrated in  FIG. 7 , the fingerhold  50  is shaped as a loop that may house a radio frequency (RF) antenna to facilitate bi-directional communication between the transvaginal stimulation device  12  and the clinician programmer  14  and patient controller  16  (shown in  FIG. 2 ), as described above. 
     As shown in  FIGS. 6B and 6E , the minimal UI  46  can be actuated by the patient  100  to wake up the transvaginal stimulation device  12  and to communicate the state of the transvaginal stimulation device  12  to the patient  100 . The minimal UI  46  may also be actuated to turn on the transvaginal stimulation device  12  (i.e., activate the stimulation circuitry) or turn off the transvaginal stimulation device  12  (i.e., deactivate the stimulation circuitry) to provide the patient  100  an alternative means of initiating or ceasing a stimulation session, e.g., if the patient controller  16  is lost or otherwise out of reach of the patient  100 . 
     The probe body  42  may be semi-rigid or rigid and can be composed of both rigid and flexible sections. The rigid sections of the probe body  42  may be composed of a rigid biocompatible plastic, e.g., acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, or other similar plastics, and the flexible sections of the probe body  42  may be composed of a biocompatible elastomer, e.g., silicone, polyurethane, nitrile rubber, or other similar materials. The probe body  42  is sized and shaped to be fully inserted into the vaginal cavity  124  of the patient  100 , and may, e.g., take the form of a casing that hermetically contains the internal electrical components described above with respect to  FIG. 5 . Although it is preferred that the stimulation circuitry  32  be contained with the probe body  42 , in alternative embodiments, the stimulation circuitry  32  may reside outside of the probe body  42 , in which case, it can be electrically coupled to the electrodes  30   a,    30   b  via an electrical cord (not shown). 
     The probe body  42  has a stimulating side  52   a  on which the pair of electrodes  30   a,    30   b  is disposed, and a diametrically opposing non-stimulating side  52   b  completely free of electrodes, such that electrical stimulation energy can only be emitted unidirectionally from the stimulating side  52   a  of the probe body  42 . In the context of the transvaginal stimulation of the mid-urethral striated sphincter muscle  110  (shown in  FIG. 1A ), the stimulating side  52   a  can be considered the anterior face of the probe body  42 , whereas the non-stimulating side  52   b  can be considered the posterior face of the probe body  42 . As shown in  FIG. 6A , the probe body  42  has a length L extending in the longitudinal direction, a width W extending in the lateral direction, and a depth D extending perpendicularly to the length L and width W. 
     Significantly, the stimulating side  52   a  of the probe body  42  has a transversely scalloped or concave region  54  between and extending at least the length I of the electrodes  30   a,    30   b.  As can be best appreciated in  FIG. 3B , this concave region  54  of the stimulating side  52   a  facilitates location of the urethra  104  in the middle of the transvaginal stimulation device  12  equidistant between the electrodes  30   a,    30   b.  The concave region  54  of the stimulating side  52   a  conforms to the natural convex surface of the anterior wall  122  of the vagina  120  caused by the urethral carina  128  (shown in  FIG. 3B ), thereby minimizing stretching of the tissue of the anterior wall  122 , which may otherwise occur if the stimulating side  52   a  had a transversely flat or convex contour. The concave region  54  also facilitates low resistance contact of the electrodes  30   a,    30   b  with vaginal tissue and disposes the electrodes  30   a,    30   b  as close to the urethra  104  as is possible in a transvaginal approach thereby providing spatial specificity. The concave region  54  may have a radius of curvature of, e.g., 1 cm (see  FIG. 6C ), and a length commensurate with the length L of the probe body  42  (see  FIG. 6A ), such that the entire length of the urethral carina  128  will be located equidistantly between the electrodes  30   a,    30   b.    
     Much of the probe body  42  is uniquely shaped with an elliptical cross-section in the transverse plane (see  FIG. 6C ) in order to maintain its position (both longitudinally and rotationally) within the vaginal cavity  124  of the patient  100 , thereby ensuring that the electrical stimulation energy continues to be directed towards and focused on the mid-urethral striated sphincter muscle  110  of the patient  100 , even when the patient  100  is performing physical activity. 
     To this end, the length L of the probe body  42  is commensurate with the length of the vaginal cavity  124  (e.g., in the range of 4 cm-8 cm). The length L of the probe body  42  will generally be greater than the width W of the probe body  42  to mimic the vaginal cavity  124  of the patient  100 . Notably, the vaginal cavity  124  has a non-circular cross-section, and in particular, is flat and wide, with the anterior and posterior walls of the vagina  120  contacting each other. As can be seen in  FIG. 6C , the cross-sectional elliptical shape of the probe body  42  reflects the natural shape of the middle and cranial regions of the vaginal cavity  124 . Because the cross-section of the natural vaginal cavity  124  is non-circular, and in particular, has an elliptical cross-section, the probe body  42  likewise has a non-circular (in this case, an elliptical) cross-section, with the greatest lateral extent of its width W being greater than its depth D to mimic the vaginal cavity  124 . It can be appreciated that the probe body  42  mimics the non-circular cross-section of the vaginal cavity  124 , thereby resisting rotation of the transvaginal stimulation device  12  relative to the vaginal cavity  124 . In contrast, a cylindrical probe body having a circular cross-section would provide little to no resistance to rotation of the transvaginal stimulation device  12  within the vaginal cavity  124 . 
     The cross-section in the transverse plane (both width W and depth D) of the probe body  42  along its length L is also uniquely shaped to ensure that the transvaginal stimulation device  12  is properly seated axially within the vaginal cavity  124  of the patient  100  in a stable and repeatable manner. In this manner, the electrodes  30   a,    30   b  will be axially aligned with the mid-urethral striated sphincter muscle  110  of the patient  100  in a consistent manner once the transvaginal stimulation device  12  is inserted in the vaginal cavity  124  of the patient  100 . 
     To this end, the width W at the proximal region  43  of the probe body  42  laterally flares outward in the proximal direction to form shoulders  56 , and then laterally tapers inward in the proximal direction to its narrowest point to form a waist  58 , as best shown in  FIG. 6E . In the embodiment illustrated in  FIG. 6E , the width W 2  of the waist  58  of the probe body  42  is less than half of the width W 1  of the shoulders  56  of the probe body  42 , and preferably less than one-third of the width W 1  of the shoulders  56  of the probe body  42 . For example, the width W 2  of the waist  58  may be in the range of 1 cm-1.5 cm. The axial distance d 1  between the shoulders  56  of the probe body  42  and the waist  58  of the probe body  42  is preferably in the range of 1.0 cm to 2.0 cm, and in the illustrated embodiment, is 1.5 cm. 
     The inventors have also appreciated that the cranial end of the vaginal cavity  124  widens and angles posteriorly, and have taken advantage of this anatomical feature by shaping a distal region  45  of the probe body  42  to mimic the cranial end of the vaginal cavity  124 . In particular, as illustrated in  FIG. 6E , the width W at the distal region  45  of the probe body  42  laterally flares outward in the distal direction from a laterally narrow mid-region  47  to form the flattened scoop  60 . As illustrated in  FIG. 6F , the flattened scoop  60  is flattened, having a depth that is substantially less the depth of the mid-region  47  of the probe body  42 , and angles downward away from the stimulating  52   a  of the probe body  42  to conform to the posteriorly angled cranial end of the vaginal cavity  124 . 
     As illustrated in  FIGS. 8A and 8B , when the probe body  42  is fully disposed within the vaginal cavity  124 , the levator ani  130  exerts an inward medial compressive force on the laterally narrower mid-region  47  between the shoulders  56  and the flattened scoop  60 , thereby securely seating and facilitating retention of the transvaginal stimulation device  12  longitudinally within the vaginal cavity  124 . Thus, the probe body  42  is axially stabilized within the vaginal cavity  124 , naturally helping to prevent it from being expelled by either gravity or intraabdominal pressure. Notably, the laterally narrow mid-region  47  of the probe body  42  conforms to where a region  132  of the levator ani  130  naturally indents the lateral margins of the vagina  120  inward when the probe body  42  is fully disposed in the vaginal cavity  124 , thereby facilitating correct seating of the probe body  42  within the vaginal cavity  124 , and location and retention of the electrodes  30   a,    30   b  adjacent the mid-urethral striated sphincter muscle  120 . Furthermore, because the flattened scoop  60  is flattened, as best illustrated in  FIG. 6F , the flattened scoop  60  serves to further resist rotation of the transvaginal stimulation device  12  relative to the vaginal cavity  124 . 
     Referring to  FIG. 6A , the electrodes  30   a,    30   b  have outer exposed, electrically conductive, tissue-contacting surfaces, such that the electrodes  30   a,    30   b  may be placed into electrical contact with tissue, and in this case, the anterior wall  122  of the vagina  120  in which the transvaginal stimulation device  12  is inserted (shown in  FIG. 3A ). Significantly, as best shown in  FIG. 6C , the tissue contacting surfaces of the electrodes  30   a,    30   b,  which preferably have flattened faces, form an angle substantially equal to 180° (i.e., disposed on a plane P extending along the stimulating side  52   a  of the probe body  42 ), such that the electrodes  30   a,    30   b  are placed into firm contact with in the anterior wall  122  of the vagina  120  when the transvaginal stimulation device  12  is inserted into the vaginal cavity  124 . That is, as illustrated in  FIG. 3B , because the anterior wall  122  of the vagina  120  is generally flat (as opposed to curved about a longitudinal axis of the probe body  42 ) in nature, contact between the electrodes  30   a,    30   b  and the anterior wall  122  of the vagina  120  will be maximized if the electrodes  30   a,    30   b  are disposed along the same plane (as opposed to being disposed circumferentially relative to each other as when disposed on a cylindrical probe body), and thus, focused stimulation of the mid-urethral striated sphincter muscle  110  will be made as efficient as possible. For the purposes of this specification, the tissue contacting surfaces of the electrodes  30   a,    30   b  form an angle substantially equal to 180°, this angle being within a range of 160°-200°. Preferably, the tissue contacting surfaces of the electrodes  30   a,    30   b  form an angle within the range of 170°-190°. 
     As shown in  FIG. 6A , each of the electrodes  30   a,    30   b  preferably is elongated, i.e., has a length I substantially greater than a width w. Notwithstanding this, each of the electrodes  30   a,    30   b  preferably has a relatively short length I (e.g., in the range of 4 mm-12 mm), such that the stimulation energy is focused in the region adjacent the mid-urethral striated sphincter muscle  110 . The electrodes  30   a,    30   b  have an edge-to-edge lateral spacing s, which should not be so great that the current flowing between the electrodes  30   a,    30   b  passes through the pelvic floor, but should not be so small that the current flows between the electrodes  30   a,    30   b  without passing through the periurethral components of the patient  100 . Notably, disposing the electrodes  30   a,    30   b  on a plane along the stimulating side  52   a  of the probe body  42  facilitates minimization of the edge-to-edge lateral spacing s, which may otherwise be prohibitively increased if the electrodes  30   a,    30   b  were radially disposed radially outward relative to the plane P. The edge-to-edge spacing s between the electrodes  30   a,    30   b  is preferably in the range of 5 mm-25 mm, and more preferably in the range of 10 mm-20 mm, for optimal stimulation, although other ranges are contemplated by the invention. 
     Each of the electrodes  30   a,    30   b  has a relatively small width w (e.g., in the range of 2 mm-4 mm) to accommodate the electrodes  30   a,    30   b  (taking into account the spacing s therebetween) on the limited width of the probe body  42 , but large enough, such that the exposed outer surfaces of the electrodes  30   a,    30   b  do not have excessive current density when activated. The electrodes  30   a,    30   b  may protrude a certain distance (e.g., 1 mm) from the surface of the probe body  42 . Preferably, the transvaginal stimulation device  12  comprises no additional electrodes laterally disposed relative to the pair of electrodes  30   a,    30   b,  such that the pair of electrodes  30   a,    30   b  can convey electrical stimulation energy to the targeted periurethral structure component (in this case, the mid-urethral striated sphincter muscle  110 ) in a more focused manner. While the current flowing through electrodes  30   a,    30   b  may be similar to prior art pelvic floor stimulators, the transvaginal stimulation device  12  can stimulate the mid-urethral striated sphincter muscle  110  with considerably lower voltage and power because the mid-urethral striated sphincter muscle  110  has a lower impedance than the pelvic floor muscles. 
     Notably, since the location of each of the electrodes  30   a,    30   b  of the transvaginal stimulation device  12  illustrated in  FIGS. 6A-6F  is fixed relative to the probe body  42 , it is important that the electrodes  30   a,    30   b  be axially aligned with the mid-urethral striated sphincter muscle  110  once the transvaginal stimulation device  12  is properly seated within the vaginal cavity  124  of the patient  100 . As such, the axial centers of the electrodes  30   a,    30   b  should be located the proper distance d 2  on the probe body  42  relative to the waist  58  of the probe body  42 , as illustrated in  FIG. 6E . For example, the distance d 1  between the axial centers of the electrodes  30   a,    30   b  and the waist  58  of the probe body  42  can be in the range of 1.5 cm-2.5 cm. 
     To ensure proper seating of the waist  58  of the probe body  42  in the introitus  125  of the patient  100 , the extraction mechanism  44  of the transvaginal stimulation device  12  may alternatively be rigid. In this case, because the extraction mechanism  44  is rigid, abutment between the distal facing surface  62  of the fingerhold  50  and the pubic bone  126 , as illustrated in  FIG. 3A , prevents the probe body  42  from being inserted too far into the vaginal cavity  124 , which would otherwise result in improper seating of the transvaginal stimulation device  12  within the vaginal cavity  124  of the patient  100  relative to the urethra  104 . It should be appreciated that the distance between the pubic bone  126  and the urethral meatus (i.e., the opening to the urethra  104 ) is generally consistent between patients, and thus, the extraction mechanism  44  allows the electrodes  30   a,    30   b  to be axially located relative to the urethra  104 , as opposed to the vaginal anatomy of the patient  100 , thereby more accurately placing the electrodes  30   a,    30   b  adjacent the mid-urethral striated sphincter muscle  110  of the patient  100 . It is preferred that the fingerhold  44  be located at the 12 o&#39;clock position, since the tissue thickness at the 12 o&#39;clock position in the area of the pubic bone  126  is consistent between patients, as opposed to other positions, e.g., the 10 o&#39;clock or 2 o&#39;clock positions where the tissue thickness may vary between patients. 
     In an optional embodiment illustrated in  FIG. 9A-9C , multiple transvaginal stimulation devices  12   a - 12   c  having different distances d 2  between the electrodes  30   a,    30   b  and the waist  58  of the probe body  42  may be provided (e.g., the distances d 2  may range from 1.5 cm to 2.5 cm), such that the electrodes  30   a,    30   b  of at least one of the transvaginal stimulation devices  12   a - 12   c  are axially aligned with the mid-urethral striated sphincter muscle  110  of the patient  100  when the respective transvaginal stimulation device  12  is properly seated within the vaginal cavity  124  of the patient  100 . Thus, one of the stimulation devices  12   a - 12   c  may be judicially selected, such that distance d 2  between the electrode  30   a,    30   b  and the waist  58  matches the distance between the introitus  125  of the vaginal cavity  124  (shown in  FIG. 3A ) and the mid-urethral striated sphincter muscle  110 . 
     Referring to  FIGS. 10A and 10B , another embodiment of a transvaginal stimulation device  12 ′ has a telescoping arrangement. In particular, probe body  42  of the transvaginal stimulation  12 ′ is divided into two telescoping proximal and distal probe bodies  42   a,    42   b  that can be displayed relative to each other. The transvaginal device  12 ′ comprises a locking mechanism  64  (e.g., a collet feature or collar) that can be manipulated to lock the axial displacement between the proximal and distal probe bodies  42   a,    42   b  to ensure that the transvaginal stimulation device  12 ′ remains at the desired length. Thus, the distance d 2  between the electrodes  30   a,    30   b  and the waist  58  of the probe body  42  may be varied (e.g., the distances d 2  may range from 1.5 cm to 2.5 cm) by displacing and then locking the proximal and distal probe bodies  42   a,    42   b  relative to each other to match the distance between the introitus  125  of the vaginal cavity  124  (shown in  FIG. 3A ) and the mid-urethral striated sphincter muscle  110 , thereby facilitating axial alignment between the electrodes  30   a,    30   b  and the mid-urethral striated sphincter muscle  110  of the patient  100  when the respective transvaginal stimulation device  12 ′ is properly seated within the vaginal cavity  124  of the patient  100 . 
     Referring to  FIGS. 11A and 11B , still another embodiment of a transvaginal stimulation device  12 ″ comprises moveable electrodes  32   a,    32   b  having mechanically variable axial locations, such that the electrodes  32   a,    32   b  may be axially aligned with the periurethral structural components of the patient  100 . For example, the transvaginal stimulation device  12 ″ may have interfacing features, such as a J-channel  66  between the electrodes  32   a,    32   b  and the probe body  42  that allows the electrodes  32   a,    32   b  to be incrementally adjusted and locked in the axial direction relative to the probe body  42 , e.g., every 5 mm. Thus, the distance d 2  between the electrodes  30   a,    30   b  and the waist  58  of the probe body  42  vary be varied (e.g., the distances d 2  may range from 1.5 cm to 2.5 cm) by displacing and locking the electrodes  32   a,    32   b  to match the distance between the introitus  125  of the vaginal cavity  124  (shown in  FIG. 3A ) and the mid-urethral striated sphincter muscle  110 , thereby facilitating axial alignment between the electrodes  30   a,    30   b  and the mid-urethral striated sphincter muscle  110  of the patient  100  when the respective transvaginal stimulation device  12 ″ is properly seated within the vaginal cavity  124  of the patient  100 . 
     Although each of the transvaginal stimulation devices  12 ,  12 ′, and  12 ″ illustrated in  FIGS. 6-12  has a single pair of electrodes  30   a,    30   b,  yet another embodiment of a transvaginal stimulation device  12 ″ may comprise a pair of linear arrays of electrodes  30   a ( 1 )-( 3 ),  30   b ( 1 )-( 3 ), as illustrated in  FIG. 12 . Significantly, pairs of electrodes  30   a ( 1 )-( 3 ),  30   b ( 1 )-( 3 ) may be activated, such that the location of stimulation along the urethra  104  can be cranio-caudally varied, even though the physical location of the transvaginal stimulation device  12 , and the electrodes  30   a ( 1 )-( 3 ),  30   b ( 1 )-( 3 ), is fixed in the vaginal cavity  124  of the patient  100 . 
     A pair of electrodes  30   a ( 1 )-( 3 ),  30   b ( 1 )-( 3 ) may be selectively activated to craniocaudally vary the location (either proximally or distally) of stimulation along the urethra  104 . It is preferred that any selected pair of electrodes be activated as transverse (i.e., displaced from each other along the transverse axis) bipolar electrode combinations; i.e., the electrodes in one of the electrode arrays L, R be activated as anodes, and the electrodes in the other of the electrode arrays L, R be activated as cathodes, thereby providing the most effective bipolar stimulation to the circumferential striated muscle  110 . 
     For example, as illustrated in  FIGS. 13A-13C , different traverse bipolar pairs of electrodes in the linear array of electrodes  30   a ( 1 )-( 3 ),  30   b ( 1 )-( 3 ) (respectively designated “L 1 -L 3 ” and “R 1 -R 3 ”) can be activated to vary the location of stimulation relative to the urethra  104  in order to focus the stimulation over the circumferential striated muscle  110 . For example, one transverse bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L 1  versus electrode R 1 ) may be activated for a more cranial stimulation location (i.e., a more caudally located mid-urethral striated sphincter muscle  110 ), as illustrated in  FIG. 13A ; another transverse bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L 2  versus electrode R 2 ) may be activated for a medial stimulation location, as illustrated in  FIG. 13B ; and still another transverse bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L 3  versus electrode R 3 ) may be activated for a more caudal stimulation location, as illustrated in  FIG. 13C . 
     In an optional technique, the different transverse bipolar pairs of electrodes L 1 -L 3 , R 1 -R 3  may be cycled to actively move the stimulation location in the cranial-caudal direction relative to the urethral  104  by sequentially activating transverse bipolar electrode pairs in a wave in a single stimulation regimen. For example, the transverse bipolar electrode pairs may be sequentially activated in the caudal direction (e.g., by activating electrode L 1  versus electrode R 1 , then electrode L 2  versus electrode R 2 , and then electrode L 3  versus electrode R 3 ) and/or in the cranial direction (by activating electrode L 3  versus electrode R 3 , then electrode L 2  versus electrode R 2 , then electrode L 3  versus electrode R 3 ). The transverse bipolar pairs of electrodes L 1 -L 3 , R 1 -R 3  may be activated in any order, and one pair of electrodes may be activated more or less than another transverse bipolar pair of electrodes, as long as each electrode pair is activated at least once in the single stimulation regimen. 
     While it is believed that specifically targeting the mid-urethral striated sphincter muscle  110  for stimulation is the most effective way to treat SUI of the patient  100 , it should be appreciated that there may be circumstances where supplemental stimulation of other periurethral structural components of the patient  100  (e.g., the circumferential smooth muscle  112  and/or the longitudinal smooth muscle  114 ) may be desirable. In this case, the stimulation regimen may not be limited to the activation of a single transverse pair of electrodes  30   a,    30   b  in a bipolar fashion. 
     In one embodiment, transverse multipolar subsets of electrodes L 1 -L 3 , R 1 -R 3  may be activated, as illustrated in  FIGS. 13D-13F , thereby providing the most effective stimulation to both the circumferential striated muscle  110  and the circumferential smooth muscle  112 . For example, two electrodes in the linear electrode array L may be activated with one polarization, and two electrodes in the linear electrode array R may be activated with another polarization (e.g., by activating electrodes L 1 +L 2  versus electrodes R 1 +R 2 , as shown in  FIG. 13D , or by activating electrodes L 2 +L 3  versus electrodes R 2 +R 3 , as shown in  FIG. 13E ). As another example, three electrodes in the linear electrode array L may be activated with one polarization, and three electrodes in the linear electrode array R may be activated with another polarization (in this case, by activating electrodes L 1 +L 2 +L 3  versus electrodes R 1 +R 2 +R 3 ), as shown in  FIG. 13F . 
     In another embodiment, longitudinal (i.e., displaced from each other along the longitudinal axis) multipolar subsets of electrodes L 1 -L 3 , R 1 -R 3  may be activated, as illustrated in  FIGS. 13G-13L , thereby providing the most effective stimulation to the longitudinal smooth muscle  114 . For example, one longitudinal bipolar pair of electrodes in the linear electrode array L (e.g., electrode L 1  versus electrode L 2 ) may be activated, as illustrated in  FIG. 13G ; another longitudinal bipolar pair of electrodes in the linear electrode array R (e.g., electrode R 1  versus electrode R 2 ) may be activated, as illustrated in  FIG. 13H ; still another longitudinal bipolar pair of electrodes in the linear electrode array L (e.g., electrode L 2  versus electrode L 3 ) may be activated, as illustrated in  FIG. 13I ; yet another longitudinal bipolar pair of electrodes in the linear electrode array L (e.g., electrode R 2  versus electrode R 3 ) may be activated, as illustrated in  FIG. 13J ; yet another longitudinal bipolar pair of electrodes in the linear electrode array L (e.g., electrode L 1  versus electrode L 3 ) may be activated, as illustrated in  FIG. 13K ; and yet another longitudinal bipolar pair of electrodes in the linear electrode array R (e.g., electrode R 1  versus electrode R 3 ) may be activated, as illustrated in  FIG. 13L . As another example, two electrodes respectively in the linear electrode arrays L, R may be activated with one polarization, and two electrodes in the linear electrode arrays L, R may be activated with another polarization (e.g., by activating electrodes L 1 +R 1  versus electrodes L 2 +R 2 , as shown in  FIG. 13M , or by activating electrodes L 1 +R 1  versus electrodes L 3 +R 3 , as shown in  FIG. 13N ). 
     Although bipolar pairs of electrodes have been illustrated as being orthogonal (horizontally and vertically disposed), bipolar pairs of electrodes may be diagonally disposed relative to each other. For example, one diagonal bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L 1  versus electrode R 3 ) may be activated, as illustrated in  FIG. 13O ; and another diagonal bipolar pair of electrodes in the linear electrode arrays L, R (e.g., electrode L 3  versus R 1 ) may be activated, as illustrated in  FIG. 13P . 
     Having described the structure and function of the SUI treatment system  10 , one method  150  of using the SUI treatment system to treat SUI in the patient  100  will now be described. Referring to  FIG. 14 , the transvaginal stimulation device  12  (or alternatively, any of the transvaginal stimulation devices  12 ,  12 ″, or  12 ″) is inserted into the vaginal cavity  124  of the patient  100 , such that scoop  60  conforms to the posteriorly angled cranial end of the vaginal cavity  124  when the probe body  42  is fully disposed in the vaginal cavity  124 , and the levator ani muscles  132  of the female patient  100  are disposed adjacent to the mid-region  47  between the flattened scoop  60  and the shoulders  56 , as illustrated in  FIGS. 3A, 8A and 8B  (step  152 ). Thus, the transvaginal stimulation device  12  will be securely seated and retained within the vaginal cavity  124 , while the stimulating side  52   a  of the probe body  42  of the transvaginal stimulation device  12  contacts the anterior wall  122  of the vagina  120 , such that the electrodes  30   a,    30   b  face the urethra  104 . Proper seating and orientation of the transvaginal stimulation device  12  can be confirmed by approximating the pubic bone  126  of the female patient  100  with the proximal surface of the fingerhold  62  of the extraction mechanism  44 . 
     Next, the transvaginal stimulation device  12  is mechanically and/or electrically fitted to the patient  100  to optimize treatment of the SUI (step  154 ). As stated above, maximum urethral closure pressure of a patient can be considered a good measure of optimized SUI treatment. As such, biofeedback in the form of urethral closure pressure measurements of the patient  100  can be used while mechanically and/or electrically fitting transvaginal stimulation device  12  to the patient  100 , such that one or more stimulation regimens (defining the stimulation parameters and axial electrode placement relative to the mid-urethral striated sphincter muscle  110  of the patient  100  (see  FIG. 1A )) can be determined. In general, it is desirable to select stimulation regimens that achieve a sufficient maximum closure pressure, while minimizing the current density on the electrodes  30   a,    30   b.    
     As one example of fitting the transvaginal stimulation device  12 , the clinician programmer  14  may be operated to convey electrical stimulation energy from the electrodes  30   a,    30   b  of the inserted transvaginal device  12 , while varying any one or more electrical stimulation parameters (e.g., varying the pulse width in the range of 0.1 ms-2 ms and/or varying the pulse frequency in the range of 20 Hz-60 Hz and/or varying the magnitude in the range of 1 mA-50 mA), to define one or more efficacious stimulation programs. 
     In the case where different sized transvaginal stimulation devices  12  are available ( FIGS. 9A-9C ), each different transvaginal stimulation device  12  may be inserted into the vaginal cavity  124  of the patient  100  to determine the optimally sized transvaginal stimulation device  12 . For example, the transvaginal stimulation device  12  having the proper distance between the electrodes  30   a,    30   b  and the waist  58  of the probe body  42 , such that the electrodes  30   a,    30   b  are coincident with the mid-urethral striated sphincter muscle  110  (i.e., the transvaginal stimulation device  12  that results in maximum urethral closure pressure) may be selected. 
     In the case where the telescoping transvaginal stimulation device  12  is used ( FIGS. 10A and 10B ), the proximal and distal body portions  42   a,    42   b  may be axially displaced relative to each other to vary the distance between the electrodes  30   a,    30   b  and the waist  58  of the probe body  42 , such that the electrodes  30   a,    30   b  are coincident with the mid-urethral striated sphincter muscle  110  (i.e., the transvaginal stimulation device  12  that results in maximum urethral closure pressure). The locking mechanism  64  can then be locked to affix the electrodes  30   a,    30   b  relative to the probe body  42 . 
     In the case where the transvaginal stimulation device  12 ″ is used ( FIGS. 11A and 11B ), the electrodes  30   a,    30   b  may be axially adjusted relative to the probe body  42  to vary the distance between the electrodes  30   a,    30   b  and the waist  58  of the probe body  42 , such that the electrodes  30   a,    30   b  are coincident with the mid-urethral striated sphincter muscle  110  (i.e., the transvaginal stimulation device  12  that results in maximum urethral closure pressure). 
     In the case where the transvaginal stimulation device  12 ″ is used ( FIG. 12 ), different pairs of the electrode  30   a,    30   b  can be activated to determine the pair of electrodes  30   a,    30   b  that is coincident with the mid-urethral striated sphincter muscle  110  (i.e., the transvaginal stimulation device  12  that results in maximum urethral closure pressure). The clinician programmer  14  may be operated to automatically sequence through various combinations of electrode pairs and other electrical stimulation parameters while maintaining the electrical current at an effective, but comfortable, level, e.g., in the range of 1 mA-50 mA. The frequency of the electrical stimulation energy may have a range of, e.g., 5 Hz-50 Hz. 
     Next, the clinician programmer  14  is operated to program the transvaginal stimulation device  12  with optimized stimulation program(s) (defining the location of the electrodes  30   a,    30   b  in the case of the transvaginal stimulation device  12 ″, as well as the pulse width, pulse frequency, and pulse amplitude (step  156 ). The transvaginal stimulation device  12  may then be operated to initiate stimulation session by transvaginally conveying electrical stimulation energy uni-directionally through the anterior wall  122  of the vagina  120  in accordance with one or more stimulation programs. For example, the patient  100  may operate the patient controller  16  (or alternatively, the minimal UI  46 ) to activate the transvaginal stimulation device  12  and select the stimulation program(s). During the stimulation session, the mid-urethral striated sphincter muscle  110  is stimulated to treat the SUI of the patient  100  without substantially stimulating pelvic floor muscles of the patient  100  (step  160 ). The transvaginal stimulation device  12  may then automatically terminate the stimulation session, e.g., in accordance with a predetermined cycle (step  162 ). Alternatively, the transvaginal stimulation device  12  may be manually terminated, e.g., by operating the patient controller  16  (or alternatively, the minimal UI  46 ) to deactivate the transvaginal stimulation device  12 . It is contemplated that the patient  100  will require approximately 15 minutes of treatment time every day for at least 8-12 weeks to hypertrophy the periurethral structural components, and more particularly, the mid-urethral striated sphincter muscle  110 . 
     Although particular embodiments of the disclosed inventions have been shown and described herein, it will be understood by those skilled in the art that they are not intended to limit the disclosed inventions, and it will be obvious to those skilled in the art that various changes and modifications may be made (e.g., the dimensions of various parts) without departing from the scope of the disclosed inventions, which is to be defined only by the following claims and their equivalents. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The various embodiments of the disclosed inventions shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed inventions, which may be included within the scope of the appended claims. 
     In addition to the appended claims, additional specific embodiments of the disclosed inventions, including in each case all essential limitations, include without limitation: 
     A transvaginal stimulation device, comprising: a probe body sized to fit entirely within a vaginal cavity of a female patient, the probe body having a length extending in a longitudinal direction, a width extending in a lateral direction, and a depth being perpendicular to the length and width, the probe body having a stimulating side defined by the length and the width of the probe body; and a transverse bipolar pair of electrodes disposed on the stimulating side of the probe body and laterally spaced from each other, wherein the pair of electrodes have an edge-to-edge lateral spacing in a range between 5 mm and 25 mm. 
     The transvaginal stimulation device of paragraph [0099], wherein the probe body has a concave region longitudinally extending along the stimulating side of the probe body, and wherein the concave region is shaped to cradle a urethra carina of the female patient when the probe body is positioned in a vaginal cavity. 
     The transvaginal stimulation device of paragraphs [0099] or [00100], wherein the probe body is rigid or semi-rigid. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00101], wherein the length of the probe body is in a range between 4 cm and 8 cm. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00102], wherein the width of the probe body has a greatest lateral extent that is greater than the depth of the probe body. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00103], wherein a distal region of the probe body laterally flares outward in a distal direction from a mid-region of the probe body to form a flattened scoop. 
     The transvaginal stimulation device of paragraph [00104], wherein the flattened scoop angles away from the stimulating side of the probe body. 
     The transvaginal stimulation device of paragraph [00104] or [00105], wherein a proximal region of the probe body laterally flares outward in a proximal direction from the mid-region to form shoulders. 
     The transvaginal stimulation device of paragraph [00106], wherein the mid-region of the probe body is sized and configured, such that when the probe body is fully disposed in the vaginal cavity, levator ani muscles of the female patient are disposed adjacent to the mid-region between the flattened scoop and the shoulders. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00107], wherein the transvaginal stimulation device is free of any electrodes laterally disposed relative to the pair of electrodes. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00108], wherein the probe body has a non-stimulating side opposite the stimulating side of the probe body, wherein the non-stimulating side of the probe body is free of any electrode. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00108], wherein each electrode of the transverse bipolar pair of electrodes has an elongated shape, and wherein the electrodes are disposed parallel to each other. 
     The transvaginal stimulation device of paragraph [00110], wherein the transverse bipolar pair of electrodes respectively have lengths extending along the length of the probe body in a range between 4 mm and 12 mm. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00111], wherein the pair of electrodes have an edge-to-edge lateral spacing in a range between 10 mm and 20 mm. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00112], wherein the transverse bipolar pair of electrodes includes a first electrode having a first flat tissue contacting surface and a second electrode having a second flat tissue contacting surface tissue. 
     The transvaginal stimulation device of paragraph [00113], wherein the first tissue contacting surface and the second tissue contacting surface form an angle within a range between 160° and 200°. 
     The transvaginal stimulation device of paragraph [00113], wherein the first tissue contacting surface and the second tissue contacting surface form an angle within a range between 170° and 190°. 
     The transvaginal stimulation device of paragraph [00113], wherein the first tissue contacting surface and the second tissue contacting surface form an angle of 180°. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00116], wherein the transverse bipolar pair of electrodes are respectively positioned on the probe body, so that when the probe body is positioned in a vaginal cavity of the female patient, bipolar electrical stimulation energy delivered between the pair of electrodes stimulates at least one muscle of a urethral sphincter of the female patient without substantially stimulating pelvic floor muscles of the female patient. 
     The transvaginal stimulation device of paragraph [00117], wherein the at least one muscle of the urethral sphincter comprises a mid-urethral striated sphincter muscle. 
     The transvaginal stimulation device of paragraph [00117] or [00118], wherein the at least one muscle of the urethral sphincter comprises one or both of a circumferential smooth muscle and a longitudinal smooth muscle. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00119], further comprising stimulation circuitry contained within the probe body, the stimulation circuitry configured for delivering bipolar electrical stimulation energy between the pair of electrodes. 
     The transvaginal stimulation device of paragraph [00120], further comprising a user interface disposed on the probe body, the user interface configured for deactivating the stimulation circuitry. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00121], further comprising an extraction element extending proximally from the probe body configured for being grasped to extract the probe body from the vaginal cavity of the female patient. 
     The transvaginal stimulation device of claim  64 , wherein the extraction mechanism comprises a fingerhold having a proximal surface configured for approximating a pubic bone of the female patient when the probe body is fully disposed in the vaginal cavity of the female patient. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00123], further comprising a pair of linear electrode arrays extending along the length of the probe body, the pair of linear electrode arrays respectively comprising the pair of electrodes. 
     The transvaginal stimulation device of paragraph [00124], wherein different subsets of electrodes of the respective pair of electrodes arrays are configured for being selectively activated. 
     The transvaginal stimulation device of paragraph [00125], wherein the different subsets of electrodes comprise different bipolar pairs of electrodes. 
     The transvaginal stimulation device of paragraph [00126], wherein the different bipolar pairs of electrodes are transverse bipolar pairs of electrodes. 
     The transvaginal stimulation device of paragraph [00126], wherein the different bipolar pairs of electrodes are longitudinal bipolar pairs of electrodes. 
     The transvaginal stimulation device of any of paragraphs [0025] to [00127], wherein the different subsets of electrodes are configured for being cyclically activated one-at-a-time. 
     The transvaginal stimulation device of any of paragraphs [0099] to [00129], wherein a proximal region of the probe body comprises shoulders that laterally taper inward in a proximal direction to form a waist. 
     The transvaginal stimulation device of paragraph [00130], wherein an axial center of the transverse bipolar pair of electrodes is distally spaced from the waist a distance in a range between 1.5 cm and 2.5 cm. 
     The transvaginal stimulation device of paragraph [00130], wherein the probe body comprises telescoping proximal and distal probe bodies configured for being axially displaced relative to each other, such that a distance between the transverse bipolar pair of electrodes and the waist of the probe body can be varied. 
     The transvaginal stimulation device of paragraph [00130], wherein the transverse bipolar pair of electrodes is configured for being axially displaced relative to the probe body, such that a distance between the pair of electrodes and the waist of the probe body can be varied. 
     A transvaginal stimulation system, comprising the transvaginal stimulation device of any of paragraphs [0099] to [00133]; and a clinician programmer configured for wirelessly programming the transvaginal stimulation device. 
     The transvaginal stimulation system of paragraph [00134], wherein the transvaginal stimulation device further comprises a pair of linear arrays of electrodes respectively comprising the pair of electrodes, the pair of linear electrode arrays respectively extending along length of the probe body, and the clinician programmer is configured for: determining a stimulation regimen by selectively activating different pairs of electrodes respectively in the linear electrode arrays; and programming the transvaginal stimulation device with the stimulation regimen, such that the transvaginal stimulation device is configured for conveying electrical stimulation energy between the pair of electrodes in accordance with the stimulation regimen. 
     The transvaginal stimulation system of paragraph [00134] or [00135], further comprising a patient control configured for wirelessly controlling operation of the transvaginal stimulation device. 
     A transvaginal stimulation device, comprising: a probe body sized to fit entirely within a vaginal cavity of a female patient, the probe body having a length extending in a longitudinal direction, a width extending in a lateral direction, and a depth being perpendicular to the length and width, the probe body having a stimulating side defined by the length and the width of the probe body, the probe body distally flaring outward from a mid-region to form a flattened scoop having a depth less than a depth of the mid-region; and a pair of electrodes disposed on the stimulating side of the probe body and laterally spaced from each other. 
     The transvaginal stimulation device of paragraph [00137], wherein the probe body has a concave region longitudinally extending along the stimulating side of the probe body, and wherein the concave region is shaped to cradle a urethra carina of the female patient when the probe body is positioned in a vaginal cavity of the female patient. 
     The transvaginal stimulation device of paragraph [00137] or [00138], wherein the probe body is rigid or semi-rigid. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00139], wherein the length of the probe body is in a range between 4 cm and 8 cm. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00140], wherein the width of the probe body has a greatest lateral extent that is greater than the depth of the probe body. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00141], wherein the flattened scoop angles away from the stimulating side of the probe body. 
     The transvaginal stimulation device of paragraph [00141] or [00142], wherein a proximal region of the probe body laterally flares outward in a proximal direction from the mid-region to form shoulders. 
     The transvaginal stimulation device of paragraph [00143], wherein the mid-region of the probe body is sized and configured, such that when the probe body is fully disposed in the vaginal cavity, levator ani muscles of the female patient are disposed adjacent to the mid-region between the flattened scoop and the shoulders. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00144], wherein the transvaginal stimulation device is free of any electrodes laterally disposed relative to the pair of electrodes. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00145], wherein the probe body has a non-stimulating side opposite the stimulating side of the probe body, wherein the non-stimulating side of the probe body is free of any electrode. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00146], wherein the pair of electrodes is a transverse pair of electrodes. 
     The transvaginal stimulation device of paragraph [00147], wherein the pair of electrodes each have an elongated shape and are disposed parallel to each other. 
     The transvaginal stimulation device of paragraph [00148], wherein the pair of electrodes respectively have lengths extending along the length of the probe body in a range between 4 mm and 12 mm. 
     The transvaginal stimulation device of any of paragraphs [00147] to [00149], wherein the pair of electrodes have an edge-to-edge lateral spacing in a range between 10 mm and 20 mm. 
     The transvaginal stimulation device of any of paragraphs [00147] to [00150], wherein the pair of electrodes includes a first electrode having a first flat tissue contacting surface and a second electrode having a second flat tissue contacting surface tissue. 
     The transvaginal stimulation device of paragraph [00151], wherein the first tissue contacting surface and the second tissue contacting surface form an angle within a range between 160° and 200°. 
     The transvaginal stimulation device of paragraph [00151], wherein the first tissue contacting surface and the second tissue contacting surface form an angle within a range between 170° and 190°. 
     The transvaginal stimulation device of paragraph [00151], wherein the first tissue contacting surface and the second tissue contacting surface form an angle of 180°. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00154], wherein the pair of electrodes are respectively positioned on the probe body, so that when the probe body is positioned in a vaginal cavity of the female patient, bipolar electrical stimulation energy delivered between the pair of electrodes stimulates at least one muscle of a urethral sphincter of the female patient without substantially stimulating pelvic floor muscles of the female patient. 
     The transvaginal stimulation device of paragraph [00155], wherein the at least one muscle of the urethral sphincter comprises a mid-urethral striated sphincter muscle. 
     The transvaginal stimulation device of paragraph [00155] or [00156], wherein the at least one muscle of the urethral sphincter comprises one or both of a circumferential smooth muscle and a longitudinal smooth muscle. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00157], further comprising stimulation circuitry contained within the probe body, the stimulation circuitry configured for delivering bipolar electrical stimulation energy between the pair of electrodes. 
     The transvaginal stimulation device of paragraph [00158], further comprising a user interface disposed on the probe body, the user interface configured for deactivating the stimulation circuitry. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00159], further comprising an extraction element extending proximally from the probe body configured for being grasped to extract the probe body from the vaginal cavity of the female patient. 
     The transvaginal stimulation device of paragraph [00160], wherein the extraction mechanism comprises a fingerhold having a proximal surface configured for approximating a pubic bone of the female patient when the probe body is fully disposed in the vaginal cavity. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00161], further comprising a pair of linear electrode arrays extending along the length of the probe body, the pair of linear electrode arrays respectively comprising the pair of electrodes. 
     The transvaginal stimulation device of paragraph [00162], wherein different subsets of electrodes of the respective pair of electrodes arrays are configured for being selectively activated. 
     The transvaginal stimulation device of paragraph [00163], wherein the different subsets of electrodes comprise different bipolar pairs of electrodes. 
     The transvaginal stimulation device of paragraph [00164], wherein the different bipolar pairs of electrodes are transverse bipolar pairs of electrodes. 
     The transvaginal stimulation device of paragraph [00164], wherein the different bipolar pairs of electrodes are longitudinal bipolar pairs of electrodes. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00166], wherein the different subsets of electrodes are configured for being cyclically activated one-at-a-time. 
     The transvaginal stimulation device of any of paragraphs [00137] to [00167], wherein a proximal region of the probe body comprises shoulders that laterally taper inward in a proximal direction to form a waist. 
     The transvaginal stimulation device of paragraph [00168], wherein an axial center of the pair of electrodes is distally spaced from the waist a distance in a range between 1.5 cm and 2.5 cm. 
     The transvaginal stimulation device of paragraph [00168], wherein the probe body comprises telescoping proximal and distal probe bodies configured for being axially displaced relative to each other, such that a distance between the pair of electrodes and the waist of the probe body can be varied. 
     The transvaginal stimulation device of paragraph [00168], wherein the pair of electrodes is configured for being axially displaced relative to the probe body, such that a distance between the pair of electrodes and the waist of the probe body can be varied. 
     A transvaginal stimulation system, comprising: the transvaginal stimulation device of any of paragraphs [00137] to [00171]; and a clinician programmer configured for wirelessly programming the transvaginal stimulation device. 
     The transvaginal stimulation system of paragraph [00172], wherein the transvaginal stimulation device further comprises a pair of linear arrays of electrodes respectively comprising the pair of electrodes, the pair of linear electrode arrays respectively extending along length of the probe body, and the clinician programmer is configured for: determining a stimulation regimen by selectively activating different pairs of electrodes respectively in the linear electrode arrays; and programming the transvaginal stimulation device with the stimulation regimen, such that the transvaginal stimulation device is configured for conveying electrical stimulation energy between the pair of electrodes in accordance with the stimulation regimen. 
     The transvaginal stimulation system of paragraph [00172] or [00173], further comprising a patient control configured for wirelessly controlling operation of the transvaginal stimulation device. 
     An intravaginal device, comprising: a probe body sized to fit entirely within a vaginal cavity of a female patient, the probe body having a length extending in a longitudinal direction, a width extending in a lateral direction, and a depth being perpendicular to the length and width, the probe body having a stimulating side defined by the length and the width of the probe body; an extraction mechanism including an elongated tail member affixed to the proximal region of the probe body; and a pair of electrodes disposed on the stimulating side of the probe body and laterally spaced from each other. 
     The transvaginal stimulation device of paragraph [00175], wherein the probe body has a concave region longitudinally extending along the stimulating side of the probe body, and wherein the concave region is shaped to cradle a urethra carina of the female patient when the probe body is positioned in the vaginal cavity. 
     The transvaginal stimulation device of paragraph [00175] or [00176], wherein the probe body is rigid or semi-rigid. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00177], wherein the length of the probe body is in a range between 4 cm and 8 cm. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00178], wherein the width of the probe body has a greatest lateral extent that is greater than the depth of the probe body. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00179], wherein a distal region of the probe body laterally flares outward in a distal direction from a mid-region of the probe body to form a flattened scoop that angles away from the stimulating side of the probe body. 
     The transvaginal stimulation device of paragraph [00180], wherein a proximal region of the probe body laterally flares outward in a proximal direction from the mid-region to form shoulders. 
     The transvaginal stimulation device of paragraph [00180], wherein the mid-region of the probe body is sized and configured, such that when the probe body is fully disposed in the vaginal cavity, levator ani muscles of the female patient are disposed adjacent to the mid-region between the flattened scoop and the shoulders. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00182], wherein the transvaginal stimulation device is free of any electrodes laterally disposed relative to the pair of electrodes. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00183], wherein the probe body has a non-stimulating side opposite the stimulating side of the probe body, wherein the non-stimulating side of the probe body is free of any electrode. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00184], wherein the pair of electrodes is a transverse pair of electrodes. 
     The transvaginal stimulation device of paragraph [00185], wherein the pair of electrodes each have an elongated shape and are disposed parallel to each other. 
     The transvaginal stimulation device of paragraph [00186], wherein the pair of electrodes respectively have lengths extending along the length of the probe body in a range between 4 mm and 12 mm. 
     The transvaginal stimulation device of any of paragraphs [00185] to [00187], wherein the pair of electrodes have an edge-to-edge lateral spacing in a range between 10 mm and 20 mm. 
     The transvaginal stimulation device of any of paragraphs [00185] to [00188], wherein the pair of electrodes includes a first electrode having a first flat tissue contacting surface and a second electrode having a second flat tissue contacting surface tissue. 
     The transvaginal stimulation device of paragraph [00189], wherein the first tissue contacting surface and the second tissue contacting surface form an angle within a range between 160° and 200°. 
     The transvaginal stimulation device of paragraph [00189], wherein the first tissue contacting surface and the second tissue contacting surface form an angle within a range between 170° and 190°. 
     The transvaginal stimulation device of paragraph [00189], wherein the first tissue contacting surface and the second tissue contacting surface form an angle of 180°. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00192], wherein the pair of electrodes are respectively positioned on the probe body, so that when the probe body is positioned in the vaginal cavity, bipolar electrical stimulation energy delivered between the pair of electrodes stimulates at least one muscle of a urethral sphincter of the female patient without substantially stimulating pelvic floor muscles of the female patient. 
     The transvaginal stimulation device of paragraph [00193], wherein the at least one muscle of the urethral sphincter comprises a mid-urethral striated sphincter muscle. 
     The transvaginal stimulation device of paragraph [00193] or [00194], wherein the at least one muscle of the urethral sphincter comprises one or both of a circumferential smooth muscle and a longitudinal smooth muscle. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00195], further comprising stimulation circuitry contained within the probe body, the stimulation circuitry configured for delivering bipolar electrical stimulation energy between the pair of electrodes. 
     The transvaginal stimulation device of paragraph [00196], further comprising a user interface disposed on the probe body, the user interface configured for deactivating the stimulation circuitry. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00195], wherein the extraction mechanism comprises a fingerhold having a proximal surface configured for approximating a pubic bone of the female patient when the probe body is fully disposed in the vaginal cavity of the female patient. 
     he transvaginal stimulation device of any of paragraphs [00175] to [00198], further comprising a pair of linear electrode arrays extending along the length of the probe body, the pair of linear electrode arrays respectively comprising the pair of electrodes. 
     The transvaginal stimulation device of paragraph [00199], wherein different subsets of electrodes of the respective pair of electrodes arrays are configured for being selectively activated. 
     The transvaginal stimulation device of paragraph [00200], wherein the different subsets of electrodes comprise different bipolar pairs of electrodes. 
     The transvaginal stimulation device of paragraph [00201], wherein the different bipolar pairs of electrodes are transverse bipolar pairs of electrodes. 
     The transvaginal stimulation device of paragraph [00201], wherein the different bipolar pairs of electrodes are longitudinal bipolar pairs of electrodes. 
     The transvaginal stimulation device of any of paragraphs [00200] to [00203], wherein the different subsets of electrodes are configured for being cyclically activated one-at-a-time. 
     The transvaginal stimulation device of any of paragraphs [00175] to [00198], wherein a proximal region of the probe body comprises shoulders that laterally taper inward in a proximal direction to form a waist. 
     The transvaginal stimulation device of paragraph [00205], wherein an axial center of the pair of electrodes is distally spaced from the waist a distance in a range between 1.5 cm and 2.5 cm. 
     The transvaginal stimulation device of paragraph [00205], wherein the probe body comprises telescoping proximal and distal probe bodies configured for being axially displaced relative to each other, such that a distance between the pair of electrodes and the waist of the probe body can be varied. 
     The transvaginal stimulation device of paragraph [00205], wherein the pair of electrodes is configured for being axially displaced relative to the probe body, such that a distance between the pair of electrodes and the waist of the probe body can be varied. 
     A transvaginal stimulation system, comprising: the transvaginal stimulation device of any of paragraphs [00175] to [00208]; and a clinician programmer configured for wirelessly programming the transvaginal stimulation device. 
     The transvaginal stimulation system of paragraph [00209], wherein the transvaginal stimulation device further comprises a pair of linear arrays of electrodes respectively comprising the pair of electrodes, the pair of linear electrode arrays respectively extending along length of the probe body, and the clinician programmer is configured for: determining a stimulation regimen by selectively activating different pairs of electrodes respectively in the linear electrode arrays; and programming the transvaginal stimulation device with the stimulation regimen, such that the transvaginal stimulation device is configured for conveying electrical stimulation energy between the pair of electrodes in accordance with the stimulation regimen. 
     The transvaginal stimulation system of paragraph [00209] or [00210], further comprising a patient control configured for wirelessly controlling operation of the transvaginal stimulation device. 
     A transvaginal stimulation device, comprising: a probe body sized to fit entirely within a vaginal cavity of a female patient, the probe body having a length extending in a longitudinal direction, a width extending in a lateral direction, and a depth being perpendicular to the length and width, the probe body having a stimulating side defined by the length and the width of the probe body; and a transverse pair of electrodes disposed on the stimulating side of the probe body and laterally spaced from each other, wherein the pair of electrodes includes a first electrode having a first flat tissue contacting surface and a second electrode having a second flat tissue contacting surface tissue that forms an angle with the first tissue contact surface within a range between 160° and 200°. 
     The transvaginal stimulation device of paragraph [00212], wherein the probe body has a concave region longitudinally extending along the stimulating side of the probe body, and wherein the concave region is shaped to cradle a urethra carina of the female patient when the probe body is positioned in the vaginal cavity. Optionally, the probe body may be rigid or semi-rigid. 
     The transvaginal stimulation device of paragraph [00212] or [00213], wherein the length of the probe body is in a range between 4 cm and 8 cm. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00214], wherein the width of the probe body has a greatest lateral extent that is greater than the depth of the probe body. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00215], wherein a distal region of the probe body laterally flares outward in a distal direction from a mid-region of the probe body to form a flattened scoop that angles away from the stimulating side of the probe body. 
     The transvaginal stimulation device of paragraph [00215] or [00216], wherein a proximal region of the probe body laterally flares outward in a proximal direction from the mid-region to form shoulders. Optionally, the mid-region of the probe body is sized and configured, such that when the probe body is fully disposed in the vaginal cavity, levator ani muscles of the female patient are disposed adjacent to the mid-region between the flattened scoop and the shoulders. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00217], wherein the transvaginal stimulation device is free of any electrodes laterally disposed relative to the pair of electrodes. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00218], wherein the probe body has a non-stimulating side opposite the stimulating side of the probe body, wherein the non-stimulating side of the probe body is free of any electrode. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00219], wherein the pair of electrodes each have an elongated shape and are disposed parallel to each other. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00220], wherein the pair of electrodes respectively have lengths extending along the length of the probe body in a range between 4 mm and 12 mm. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00221], wherein the pair of electrodes have an edge-to-edge lateral spacing in a range between 10 mm and 20 mm. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00222], wherein the first tissue contacting surface and the second tissue contacting surface form an angle within a range between 170° and 190°. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00223], wherein the first tissue contacting surface and the second tissue contacting surface form an angle of 180°. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00224], wherein the pair of electrodes are respectively positioned on the probe body, so that when the probe body is positioned in a vaginal cavity of the female patient, bipolar electrical stimulation energy delivered between the pair of electrodes stimulates at least one muscle of a urethral sphincter of the female patient without substantially stimulating pelvic floor muscles of the female patient. 
     The transvaginal stimulation device of paragraph [00225], wherein the at least one muscle of the urethral sphincter comprises a mid-urethral striated sphincter muscle. 
     The transvaginal stimulation device of paragraph [00225] or [00226], wherein the at least one muscle of the urethral sphincter comprises one or both of a circumferential smooth muscle and a longitudinal smooth muscle. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00227], further comprising stimulation circuitry contained within the probe body, the stimulation circuitry configured for delivering bipolar electrical stimulation energy between the pair of electrodes. Optionally, the transvaginal stimulation device may further comprise a user interface disposed on the probe body, the user interface configured for deactivating the stimulation circuitry. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00228], further comprising an extraction element extending proximally from the probe body configured for being grasped to extract the probe body from the vaginal cavity of the female patient. Without limitation, the extraction mechanism may comprise a fingerhold having a proximal surface configured for approximating a pubic bone of the female patient when the probe body is fully disposed in the vaginal cavity. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00229], further comprising a pair of linear electrode arrays extending along the length of the probe body, the pair of linear electrode arrays respectively comprising the pair of electrodes. Without limitation, different subsets of electrodes of the respective pair of electrodes arrays may be configured for being selectively activated. Without limitation, the different subsets of electrodes may comprise different bipolar pairs of electrodes, which may optionally be transverse bipolar pairs of electrodes or longitudinal bipolar pairs of electrodes. Without limitation, the different subsets of electrodes may be configured for being cyclically activated one-at-a-time. 
     The transvaginal stimulation device of any of paragraphs [00212] to [00230], wherein a proximal region of the probe body comprises shoulders that laterally taper inward in a proximal direction to form a waist. Optionally, an axial center of the pair of electrodes may be distally spaced from the waist a distance in a range between 1.5 cm and 2.5 cm. Optionally, the probe body may comprise telescoping proximal and distal probe bodies configured for being axially displaced relative to each other, such that a distance between the pair of electrodes and the waist of the probe body can be varied. Optionally, the pair of electrodes may be configured for being axially displaced relative to the probe body, such that a distance between the pair of electrodes and the waist of the probe body can be varied. 
     A transvaginal stimulation system, comprising: the transvaginal stimulation device of any of paragraphs [00212] to [00231]; and a clinician programmer configured for wirelessly programming the transvaginal stimulation device. The transvaginal stimulation system may optionally further include a pair of linear arrays of electrodes respectively comprising the pair of electrodes, the pair of linear electrode arrays respectively extending along length of the probe body, in which case the clinician programmer may be configured for: determining a stimulation regimen by selectively activating different pairs of electrodes respectively in the linear electrode arrays; and programming the transvaginal stimulation device with the stimulation regimen, such that the transvaginal stimulation device is configured for conveying electrical stimulation energy between the pair of electrodes in accordance with the stimulation regimen. Optionally, the transvaginal stimulation system may further include a patient control configured for wirelessly controlling operation of the transvaginal stimulation device. 
     A method for treating stress urinary incontinence in a female patient using a transvaginal stimulation device comprising a probe body and a pair of electrodes disposed on the probe body, the method comprising: inserting the intravaginal device into a vaginal cavity of the female patient; positioning the pair of electrodes against an anterior wall of the vagina of the female patient; and conveying stimulation energy between the pair of electrodes to stimulate at least one muscle of a urethral sphincter muscle of the female patient without substantially stimulating pelvic floor muscles of the female patient. Optionally, the probe body may be provided with a concave region longitudinally extending along the probe body, wherein the method may further comprise cradling a urethra carina of the female patient when the probe body is inserted in the vaginal cavity. Optionally, the probe body may be rigid or semi-rigid. 
     The method of paragraph [00233], wherein the length of the probe body is in a range between 4 cm and 8 cm. 
     The method of paragraph [00233] or [00234], wherein the width of the probe body has a greatest lateral extent that is greater than the depth of the probe body, thereby preventing rotation of the probe body relative to the vaginal cavity. 
     The method of any of paragraphs [00233] to [00235], wherein a distal region of the probe body laterally flares outward in a distal direction from mid-region in the lateral direction to form a flattened scoop, and a proximal region of the probe body laterally flares outward in a proximal direction from the mid-region to form shoulders, wherein the levator ani muscles of the female patient are disposed adjacent to the mid-region between the flattened scoop and the shoulders when the probe body is fully disposed in the vaginal cavity. Optionally, the flattened scoop angles away from the stimulating side of the probe body, such that the flattened scoop conforms to a posteriorly angled cranial end of the vaginal cavity when the probe body is fully disposed in the vaginal cavity. 
     The method of any of paragraphs [00233] to [00236], wherein the stimulation energy is unidirectionally conveyed through an anterior wall of a vagina of the female patient to stimulate the urethral sphincter muscle of the female patient without substantially stimulating pelvic floor muscles of the female patient. 
     The method of any of paragraphs [00233] to [00237], wherein the stimulation energy is transverse bipolar stimulation energy. Optionally, the pair of electrodes may each have an elongated shape and are disposed parallel to each other. Optionally, each electrode of the pair of electrodes respectively may have a length extending along the length of the probe body in a range between 4 mm and 12 mm. Optionally, the pair of electrodes may have an edge-to-edge lateral spacing in a range between 5 mm and 25 mm. Optionally, the pair of electrodes may have an edge-to-edge lateral spacing in a range between 10 mm and 20 mm. Optionally, the pair of electrodes includes a first electrode having a first flat tissue contacting surface and a second electrode having a second flat tissue contacting surface tissue, wherein the first tissue contacting surface and the second tissue contacting surface form an angle within a range between 160° and 200°, an angle within a range between 170° and 190°, or an angle of 180°. 
     The method of any of paragraphs [00233] to [00238], wherein the at least one muscle of the urethral sphincter comprises a mid-urethral striated sphincter muscle. 
     The method of any of paragraphs [00233] to [00239], wherein the at least one muscle of the urethral sphincter comprises one or both of a circumferential smooth muscle and a longitudinal smooth muscle. 
     The method of any of paragraphs [00233] to [00240], wherein the stimulation energy is delivered by stimulation circuitry contained within the probe body. 
     The method of any of paragraphs [00233] to [00241], further comprising terminating the stimulation energy conveyed between the electrodes by actuating a user interface disposed on the probe body. 
     The method of any of paragraphs [00233] to [00242], further comprising extracting the probe body from the vaginal cavity by grasping an extraction element extending proximally from the probe body. Optionally, the extraction mechanism may comprise a fingerhold having a proximal surface, in which case the method may further comprise approximating the pubic bone of the female patient when the probe body is fully disposed in the vaginal cavity. 
     The method of any of paragraphs [00233] to [00243], further comprising: measuring a urethral closing pressure of the female patient while applying the stimulation energy to the urethral sphincter muscle of the female patient in accordance with a stimulation regimen; and controlling the stimulation regimen in response to the measured urethral closing pressure. Without limitation, controlling the stimulation regimen may comprise determining a stimulation regimen by selectively activating different pairs of electrodes arranged in a pair of linear electrode arrays extending along the length of the probe body, and programming the transvaginal stimulation device with the stimulation regimen, such that the transvaginal stimulation device is configured for conveying the electrical stimulation energy between the pair of electrodes in accordance with the stimulation regimen. Optionally, the different pairs of electrodes may be transverse bipolar pairs of electrodes or longitudinal bipolar pairs of electrodes. Optionally, the method may further comprise cyclically conveying stimulation energy between the different pairs of electrodes one-at-a-time to stimulate the at least one muscle of the urethral sphincter muscle of the female patient without substantially stimulating pelvic floor muscles of the female patient. 
     The method of any of paragraphs [00233] to [00244], further comprising mechanically fitting the transvaginal stimulation device to the female patient. Without limitation, mechanically fitting the transvaginal stimulation device to the female patient may comprise axially displacing the pair of electrodes relative to the probe body to vary a distance between the pair of electrodes and the waist of the probe body. Alternatively, mechanically fitting the transvaginal stimulation device to the female patient may comprise inserting a plurality of different intravaginal stimulation devices into the vaginal cavity, the transvaginal stimulation devices having different distances between a pair of electrodes and waists of the probe bodies of the transvaginal stimulation devices, and selecting the intravaginal stimulation devices from the plurality of different intravaginal stimulation devices. Without limitation, a proximal region of the probe body may comprise shoulders that laterally taper inward in a proximal direction to form a waist, wherein an axial center of the pair of electrodes is distally spaced from the waist a distance in the range of 1.5 cm-2.5 cm. Alternatively, and without limitation, the probe body may comprise telescoping proximal and distal probe bodies, wherein mechanically fitting the transvaginal stimulation to the female patient comprises axially displacing the telescoping probe bodies relative to each other to vary a distance between the pair of electrodes and the waist of the probe body. 
     The method of any of paragraphs [00233] to [00245], further comprising wirelessly controlling operation of the transvaginal stimulation device via a patient control device.