Patent Publication Number: US-11648100-B2

Title: Systems and methods for incontinence control

Description:
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/235,423, filed on Dec. 28, 2018, now U.S. Pat. No. 10,869,746, which is a continuation of U.S. patent application Ser. No. 15/462,222, filed on Mar. 17, 2017, now abandoned, both of which are incorporated by reference in their entirety herein for all purposes. Priority is claimed pursuant to 35 U.S.C. § 120. 
    
    
     FIELD OF THE INVENTION 
     The field of the invention generally relates to devices for treating urinary incontinence. 
     BACKGROUND 
     Urinary incontinence is a troublesome problem for many individuals. Urinary stress incontinence is a particular form of urinary incontinence wherein a physical occurrence may cause unwanted leakage of urine. For example, a sudden spike in abdominal pressure from sneezing, coughing or exercise may exceed the resistive pressure of the urethra for a brief moment, causing an involuntary leakage of urine. Stress urinary incontinence occurs predominantly in adult women, but may also occur in certain male or in younger females. 
     Absorbent pads are available which absorb urine after it has leaked and contain it within the wearer&#39;s undergarments. Adult diapers or absorbent panties or underwear may also be used to absorb the urine. Plastic pants designed to fit over undergarments are another means of protecting outer clothing for urine which has leaked. All of these products have the disadvantage of being forced to contain the wetness and odor of leaked urine. 
     More recently, urinary incontinence patches which are adhesively applied directly over the urethral meatus have been used in women with the intent of more completely sealing the urethra, and preventing the involuntary leakage of urine. 
     SUMMARY OF THE INVENTION 
     In a first embodiment of the present disclosure, a system for managing female incontinence includes a body of biocompatible material configured to fit between the labia minora and the vestibule floor, the body having a surface configured to occlude the urethral meatus, a first adhesive layer disposed on at least a first portion of the surface and configured to provide a sealing engagement between the body and the urethral meatus, and a second adhesive layer disposed over the first adhesive layer and configured to provide a sealing engagement between the body and the urethral meatus, wherein the second adhesive layer is removable from the first adhesive layer. 
     In another embodiment of the present disclosure, a system for managing female incontinence includes a body of biocompatible material configured to fit between the labia minora and the vestibule floor, the body having a surface configured to occlude the urethral meatus, and a first adhesive layer configured to be coupled to at least a first portion of the surface so as to provide a sealing engagement between the body and the urethral meatus, wherein the first adhesive layer, when coupled to the at least a first portion of the surface is configured to be removable from the surface. 
     In still another embodiment of the present disclosure, a system for managing female incontinence includes a body of biocompatible material configured to fit between the labia minora and the vestibule floor, the body having a longitudinal axis, a ventral side configured to occlude the urethral meatus, and a dorsal side, an adhesive carried on the ventral side and configured to provide a sealing engagement between the body and the urethral meatus, and a sheet having a first end and a second end, the first end coupled to the body adjacent the dorsal side of the body and the second end configured to be free from the body, wherein the second end is configured to be grasped by a user in order to apply a removal force on the body to separate the body from the urethral meatus. 
     In yet another embodiment of the present disclosure, a system for managing female incontinence includes a body of biocompatible material configured to fit between the labia minora and the vestibule floor, the body comprising a ventral side having an adhesive carried thereon and a dorsal side, and a removable adhesive layer carried on the ventral side of the body over the adhesive, the removable adhesive layer comprising a first adhesive surface configured to provide a sealing engagement between the body and the urethral meatus and a first release liner disposed between the first adhesive surface and the adhesive of the body, wherein the removable adhesive layer is removable from the body. 
     In still another embodiment of the present disclosure, a system for managing female incontinence includes a body of biocompatible material configured to fit between the labia minora and the vestibule floor, the body having a surface configured to occlude the urethral meatus, a first adhesive layer disposed on at least a first portion of the surface and configured to provide a sealing engagement between the body and the urethral meatus, and a first sheet having a first portion and a second portion, the first portion of the first sheet coupled to the body and the second portion of the first sheet extending from a dorsal side of the body, opposite a ventral side of the body containing the surface of the body, wherein the second portion of the first sheet is configured to be grasped by a user in order to apply a removal force on the body to separate the body from at least one of the urethral meatus and the vestibule floor. 
     In yet another embodiment of the present disclosure, a method for producing a system for managing female incontinence includes obtaining a first sheet having a first surface and a second surface, obtaining a second sheet having a first portion and a second portion, coupling the first portion of the second sheet to the first sheet, such that the second portion of the second sheet extends from the second surface of the first sheet, and wherein the first sheet is configured to fit between the labia minora and the vestibule floor and the first surface of the first sheet is configured to occlude the urethral meatus. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a perspective view of a female urinary incontinence device. 
         FIG.  2    is plan view of an embodiments of the device of  FIG.  1   , showing the device installed in the external genitalia of a human female. 
         FIG.  3    is a cross-sectional view taken along line  3 - 3  of  FIG.  2   . 
         FIG.  4    is an exploded perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  5    is a perspective view of the system for controlling urinary incontinence of  FIG.  4   . 
         FIG.  6    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  7    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  8    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  9    is a side view of an adhesive layer of the system for controlling urinary incontinence of  FIG.  8   . 
         FIG.  10    is a plan view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  11    is a perspective view of an adhesive layer according to an embodiment of the present disclosure. 
         FIG.  12    is an exploded perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  13    is a perspective view of the system for controlling urinary incontinence of  FIG.  12   . 
         FIG.  14    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  15    is a rear view of the system for controlling urinary incontinence of  FIG.  14   . 
         FIG.  16    is a right side view of the system for controlling urinary incontinence of  FIG.  14   . 
         FIG.  17    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  18    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  19    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIGS.  20  and  21    are side views of a system for controlling urinary incontinence according to an embodiment of the present disclosure, demonstrating peel forces. 
         FIG.  22    is a side view of the system for controlling urinary incontinence of  FIGS.  20  and  21   , demonstrating a tensile or normal force. 
         FIG.  23    is a side view of a system for controlling urinary incontinence according to an embodiment of the present disclosure, demonstrating peel forces. 
         FIG.  24    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  25    is a perspective view of the system for controlling urinary incontinence of  FIG.  24   , being subjected to a tensile force. 
         FIG.  26    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  27    is a posterior view of the system for controlling urinary incontinence of  FIG.  26   . 
         FIG.  28    is a perspective view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  29    is a posterior view of the system for controlling urinary incontinence of  FIG.  28   , being subjected to a tensile force while being removed from a user. 
         FIG.  30    is an exploded view of a system for controlling urinary incontinence according to an embodiment of the present disclosure. 
         FIG.  31    is a perspective view of the system for controlling urinary incontinence of  FIG.  30   . 
     
    
    
     DETAILED DESCRIPTION 
     Referring first to  FIGS.  1  through  3    of the drawings, a female urinary incontinence device  10 , in accordance with a first embodiment, is shown. Any of the subsequent embodiments herein may incorporate materials, configurations, manufacturing methods, and uses described in relation to the embodiment of  FIGS.  1  through  3   . The device comprises a body  12 , formed of a resilient foam material that is biocompatible. One suitable class of materials is that of foams formed from the water actuation of prepolymers based on either toluene diisocyanate (TDI) or methylene diphenyl diisocyanate (MDI). Such prepolymers are marketed by the Dow Chemical Company, Midland, Mich., under the trademarks “HYPOL” (TDI), “HYPOL PLUS” (MDI) and “HYPOL 2002” (TDI and MDI). Other foam materials which may be used to produce the body  12  include polyurethane foam (such as HYPOL 6000), polyvinyl chloride foam, or polyolefin foam. In some embodiments, a polyvinyl chloride foam may be utilized, such as Gaska® tape supplied by Gaska Tape, Inc., Elkhart, Ind., USA, and may have a density of between about 80 kg/m 3  and about 160 kg/m 3 , or in other embodiments between about 95 kg/m 3  and about 130 kg/m 3 , or in other embodiments, about 112 kg/m 3 . In some embodiments, a polyolefin foam may be utilized, such as Softlon™ or Volara® foams, supplied by Sekisui Voltek LLC Corporation, Lawrence, Mass., USA. 
     Alternatively, the body  12  can be made of a biodegradable material, such as a cellulose or cotton fiber. A polyurethane foam can also be used, being rendered biodegradable by hydrolysis of a weak backbone link, such as an amine group. Other foam materials, such as polyolefins, can be used and made hydrolytically biodegradable by using weak links such as starches in the polymer backbones. In some embodiments, the foam may have a substantially thick skin, to allow increased handling, which is appropriate for the embodiments described herein which may increase the total amount of handling of the body  12 . 
     The body  12  includes a base  14  that has the general outline of a blunt arrowhead. In some embodiments, the base may also be slightly concave. In other embodiments, the base  14  can be made slightly convex, for example, for those users who might find such a configuration more comfortable to wear. The base  14  may have a concave, convex, or neutral posterior end  16 , as shown in  FIG.  1   , with lateral edges  18  that taper slightly toward each other as they extend toward a rounded anterior end  20 . The anterior end  20  may be somewhat narrower than the posterior end  16 , as shown in  FIG.  1   . 
     The body  12  is provided with an adhesive surface  23  for retention against the floor of the vestibule  34  of the vulva  36  as described in relation with  FIGS.  2  and  3   . In this embodiment, the base  14  is coated with an adhesive layer  22 , comprising a pressure-sensitive, hydrophilic hydrogel adhesive material. Such hydrogel adhesives are marketed by R &amp; D Medical Products, Lake Forest, Calif., USA, under the trademark “PROMEON”. In other embodiments, other hydrogel adhesives may be utilized, including those supplied by Axelgaard Manufacturing Company Ltd. Located in Fallbrook, Calif., USA, including those comprising a polyacrylate copolymer. The hydrogel composition may include from about 25 to about 50 weight percent polyvinyl pyrrolidone (PVP) or about 30 to about 40 weight percent. The polyvinyl pyrrolidone may have a weight average molecular weight in the range of about 100,000 to 600,000, or in the range of about 300,000 to 400,000. A suitable polyvinyl pyrrolidone is type NP-K90 commercially available from Irvine Scientific, Santa Ana, Calif. 
     The composition may also include polyvinyl alcohol (PVA) in a weight percentage of about 2 to about 5 or about 3 to about 4 weight percent. A particular polyvinyl alcohol is sold by the E. I. DuPont de Nemours &amp; Co. under the trade designation “Elvanol HV”. Generally speaking, polyvinyl alcohol suitably may have a weight average molecular weight in the range of about 150,000 to about 300,000, or about 170,000 to about 220,000. A particular PVA is the material available from E. I. du Pont de Nemours &amp; Co. having a stated molecular weight of about 185,000. 
     The polyvinyl alcohols may be generally at least about 75% hydrolyzed. PVA may be about 100% hydrolyzed. 
     The composition may also include about 5 to about 40 weight percent, or about 15 to about 25 weight percent polar plasticizer or humectant e.g., glycerol. Other useful polar plasticizers include propylene glycol, sorbitol, poly(ethylene)glycol, for example having a molecular weight in the range of about 200 to about 20,000, or polypropylene glycol, for example having a molecular weight in the range of about 500 to about 5,000. Other polar plasticizers or humectants will be well-known to one skilled in the hydrogel art. 
     The composition may also include the presence of about 3 to about 50 weight percent water in the resulting matrix. Deionized water is may be used. This percentage of water may provide suitable adhesiveness, tack, cohesive strength, and skin-compatibility. 
     One skilled in the art will recognize that it is possible to add small amounts of other materials to adjust the properties of the present composition for a particular end use. For example, if it is chosen to increase the tackiness of the gel, poly-2-acrylamido 2-methyl propane sulfonic acid poly (AMPS) (or its salts) may be employed. Other material which can be employed to increase tackiness include polyacrylic acid, polystyrene sulfonic acid or salts thereof, karaya, xanthan, guar or locust bean gums. Tackifiers above described may generally be present in the range of about 2 to about 20 weight percent. 
     For some applications, it may be chosen to increase the internal coherence, cohesiveness or strength of the present biomedical composition. In such instances, materials such as hydroxy propyl methyl cellulose, carboxymethyl cellulose, hydroxy propyl guar, dextran or silica may be added. One skilled in the art will recognize other materials which could be added to the composition described herein to adjust various desired properties. Generally speaking, such additives may be present in the range of about 0 to about 10 weight percent. 
     For preparation of the materials, generally speaking, a temperature-controlled, stirrable reactor may be employed. The reactor may be preheated to about 90° C., set to mix at approximately 100 revolutions per minute, and the following materials (in representative quantities): 
     1. deionized H 2 O—39 weight percent 
     2. glycerol polar plactizers (Mallinckrodt, Inc.)—22 weight percent 
     3. polyvinyl alcohol (duPont Elvanol HV)—4 weight percent 
     4. polyvinyl pyrrolidone (R &amp; D Medical Products)—35 weight percent 
     would be mixed, for example in the order indicated. The temperature of the closed mixer then would be increased to approximately 130° C. while maintaining stirring. After a temperature of approximately 130° C. is obtained, the temperature of the mixture would be decreased to approximately 95° C., the mixer subsequently turned off and the material poured onto a release paper (e.g., “Polyslick”), the gel thereby being cooled to a solid, non-liquid state. 
     Another type of adhesive that has shown good results is a mixture of poly 2-hydroxyethyl methacrylate (PHEMA) and polyethylene glycol (PEG) as a plasticizer, or general material to modify bulk characteristics. The percentage of PHEMA may range from about 45% to about 75%, with a corresponding range of PEG of about 55% to about 25%. A particular composition is about 53% to about 54% PHEMA and about 47% to about 46% PEG. Lower percentages of PHEMA yield greater adhesiveness, while higher percentages of PHEMA yield greater durability. The PEG may have a molecular weight between about 400 and about 1000. The PHEMA may be a mixture of low molecular weight PHEMA (molecular weight between about 10,000 and about 100,000) and high molecular weight PHEMA (molecular weight greater than about 100,000). The low molecular weight PHEMA provides adhesive properties, while the high molecular weight PHEMA improves adhesive structural integrity. The PHEMA mixture may be between about 10% to about 50% low molecular weight PHEMA and between about 90% and about 50% high molecular weight PHEMA, with the precise mixture being determined by the particular adhesive properties desired. 
     While a possible plasticizer is PEG, as described above, other plasticizers can be used, such as propylene glycol, polypropylene glycol (PPG), or glycerin. 
     If the body  12  is made of TDI or MDI, the material of the body  12  itself can be rendered adhesive by combining the TDI or MDI one-to-one by weight with about 0.25 to about 0.50 molar ammonium hydroxide during the water actuation of the foam. The resulting material has a surface that is positively charged, so that it will adhere to a negatively-charged mucoid surface (such as the surface of the vestibule  34  and the inner portions of the labia minora  40 ). 
     Alternatively, the entire body  12  can be formed of an adhesive, such as the PHEMA/PEG mixture described above. In many medical or body contact applications, a PHEMA is used which is made from an optical grade HEMA monomer. This optical grade HEMA monomer may, for example, have a purity of 99% and be expensive to produce and acquire. In the embodiments described within, PHEMA made from a HEMA monomer having a purity of between about 96% to about 98% can be used with good results. 
     The side of the body  12  opposite the base  14  includes a central longitudinal ridge  26  which forms the thickest part of the body  12 . The ridge  26  may also be described as a fin. If one adopts the convention that the base  14  is the “bottom” of the body  12 , then the body  12  can be defined as having a surface  27  opposite the base that slopes “downwardly” from either side of the ridge  26  toward the edges  18 , so that there is a gradual reduction in body  12  thickness from the ridge  26  to the edges  18 . Viewed another way, the body  12  can be defined as having a cross-sectional shape that narrows from the base  14  to the “top” or apex  28  of the ridge  26 . The resulting configuration is such that a lateral cross section of the body  12 , taken through the ridge  26 , produces a shape resembling a triangle with rounded corners and slightly concave sides, as shown in  FIG.  3   . Similarly, the ridge  26  has an anterior edge  30  that tapers “downwardly” from the apex  28  toward anterior end  20  of the body  12 , as shown in  FIG.  1   , so that the anterior end  20  of the body  12  is substantially reduced in thickness as compared to the posterior end  16 . 
     The female urinary incontinence device  10  may be provided with a handle or tab that is either integrally molded with the body  12 , or subsequently attached to it. In some embodiments, the handle may be a ring or loop, for example of thread, that is inserted laterally through the body  12 . The loop may be located near the anterior portion of the apex  28  of the ridge  26 , depending on the embodiment. In other embodiments, the handle may comprise a tubular portion configured to receive a finger of the user, to aid in the removal of the female urinary incontinence device  10 . In other embodiments, a tether may be coupled to the body  12 , to aid in the removal of the female urinary incontinence device  10 . Any of these elements (ridge, fin, handle, tab, ring, loop, tether) may be generally described as manipulation members or manipulation elements. Other embodiments of manipulation elements that may be used are described in U.S. Pat. No. 9,408,648, issued Aug. 9, 2016, and entitled “Systems and Methods for Incontinence Control,” which is hereby incorporated by reference in its entirety for all purposes. 
       FIGS.  2  and  3    show the female urinary incontinence device  10  installed in the external genitalia of a human female. The female urinary incontinence device  10  is installed so that the base  14  is seated against the vestibule  34  of the vulva  36 , anteriorly of the vaginal orifice  37 , thereby occluding the urethral meatus  38 . The adhesive surface  23 , provided by the adhesive layer  22  on the base  14 , is configured to seal the urethral meatus  38  to prevent the escape of urine. The lateral edges  18  and the anterior end  20  of the body  12  are tucked under the labia minora  40 . The engagement between the labia minora  40  and the sloping surface  27  enhances the retention of the body  12  in engagement with the vestibule  34 . A concavity  41  ( FIG.  2   ) in the posterior end  16  of the body  12  allows for somewhat greater surface area for engagement by the labia minora  40 , while leaving a clearance for the vaginal opening  37 . The ridge  26  extends into the interlabial space, and is configured to be exposed to facilitate manual grasping, for removal of the female urinary continence device  10 . 
     The body  12  can be provided in a number of sizes to fit a large variety of individuals. The length of the body  12  can be made to be approximately the same as the distance between the anterior lip of the vaginal orifice and the juncture of the labia minora  40 . The width of the body  12  may be chosen to conform substantially to the width of the vestibule  34 . Predetermined sizes can be trimmed individually for optimum fit. In some cases, a mold of the relevant portions of the vulva may be taken prior to sizing the pad. 
     The adhesive layer  22  not only provides a fluid-tight seal for the urethral meatus  38 , but it also minimizes slippage of the female urinary incontinence device  10 . The central ridge  26  lends rigidity that resists deformation of the body  12  and rupture of the adhesive layer  22  under fluid pressure from the urethra, thereby enhancing the fluid-tight seal provided by the body  12  against the urethral meatus  38 . It may be chosen to extend the adhesive layer  22  onto the labia-engaging surface  27 , thereby further enhancing the stability of the female urinary incontinence device  10 . 
     A female urinary incontinence device  10  constructed in accordance with the first embodiment, as described above, can be made to withstand short-term fluid pressures from the urethra in the range of up to at least about 100, and preferably about 170, centimeters of water without significant leakage, as least for a short period of time. For example, for about two seconds or greater, and preferably about three seconds or greater. Pressures on this order are those that would typically result in involuntary urine voiding in cases of stress and urge incontinence. 170 centimeters of water is the approximate maximum bear-down pressure for a typical adult human female. 
     As an option, the foam material of the body  12 , and/or the adhesive surface  23 , can be provided with a medically-active composition. An antibacterial or germicidal agent, such as silver oxide or silver azide may be used, for example. 
     In some embodiments, one or more portions of the female urinary incontinence device  10  may be biodegradable, and may be configured for flushing down toilets or in conventional sewer systems. 
     In some embodiments, the female urinary incontinence device  10  may include a substance, for example, either directly on the body  12  or on the adhesive layer  22 , wherein the substance is configured for controlling the odor of the area associated with both the urethral area and the vaginal area of the wearer. The substance may be configured to lessen, block, mask or completely eliminate one or more types of odors in the area associated with either the urethral area or the vaginal area of the wearer. In some embodiments, the substance may be configured to control vaginal-created odors, for example, odors associated with vaginal discharge. In some embodiments, the substance may be configured to control urethra-created odors, for example urethral tract odor. In some embodiments, the substance may be configured to control sweat gland-created odors. In some embodiments, the substance may be configured to control a combination of these odors. Substances for odor control which may be used are described in U.S. Pat. No. 9,408,648, issued Aug. 9, 2016, and entitled “Systems and Methods for Incontinence Control.” 
     In some embodiments, the female urinary incontinence device  10  may include a substance, for example, either directly on the body  12  or on the adhesive layer  22 , wherein the substance is configured for medical treatment. In some embodiments, the substance is configured for treatment of vaginal disorders. In some embodiments, the substance is configured for treatment of urethral disorders. In some embodiments, the substance is configured for treatment of reproductive disorders. In some embodiments, the substance is configured as a birth control treatment. In some embodiments, the substance is configured for treatment of dermatological disorders. In some embodiments, the substance is a drug. Substances for medical treatment which may be used are described in U.S. Pat. No. 9,408,648, issued Aug. 9, 2016, and entitled “Systems and Methods for Incontinence Control.” 
     Other types of gels may be incorporated into the body  12  and/or the adhesive layer  22 , including other types of hydrogels. In some embodiments, the female urinary incontinence device  10  may comprise a silicone hydrogel. In some embodiments, the silicone hydrogel may comprise a water gradient silicone hydrogel, which, when hydrated, has a first water content at a first portion of the female urinary incontinence device  10  and a second water content at a second portion of the female urinary incontinence device  10 . Exemplary silicone hydrogels which may be used are described in U.S. Pat. No. 9,555,151, issued Jan. 31, 2017, and entitled “Systems and Methods for Incontinence Control,” which is hereby incorporated by reference in its entirety for all purposes. 
     Silicone hydrogels and methods for forming devices from silicone hydrogels may be used in certain embodiments, such as those described in U.S. Publication No. 2012/0026458, filed Jul. 29, 2011, and entitled “Silicone Hydrogel Lenses with Water-Rich Surfaces,” which is hereby incorporated by reference in its entirety for all purposes. Silicone hydrogels and methods for forming devices from silicone hydrogels may be used in certain embodiments, such as those described in U.S. publication No. 2015/0094393, filed Sep. 23, 2014, and entitled “Method for Making UV-Absorbing Ophthalmic Lenses,” which is hereby incorporated by reference in its entirety for all purposes. 
     Materials and methods for forming devices may be used in certain embodiments, such as those described in U.S. Pat. No. 5,508,317, filed Aug. 4, 1994, and entitled, “Photocrosslinked Polymers,” which is hereby incorporated by reference in its entirety for all purposes. Materials and methods for forming devices may be used in certain embodiments, such as those described in U.S. Pat. No. 6,800,225, filed Jul. 14, 1994, and entitled, “Process and Device for the Manufacture of Mouldings and Mouldings Manufactured in Accordance with that Process,” which is hereby incorporated by reference in its entirety for all purposes. Materials and methods for forming devices may be used in certain embodiments, such as those described in U.S. Pat. No. 8,163,206, filed Jun. 16, 2009, and entitled, “Method for Making Silicone Hydrogel Contact Lenses,” which is hereby incorporated by reference in its entirety for all purposes. 
       FIGS.  4  and  5    illustrate a system for controlling urinary incontinence  100  having a longitudinal axis  102 , a posterior end  104 , an anterior end  106 , a left lateral end  108 , a right lateral end  110 , a dorsal side  112 , and a ventral side  114 . The terms “left” and “right” are chosen to coincide with alignment with the sides of the user when the system for controlling urinary incontinence  100  is being worn by the user. The system for controlling urinary incontinence  100  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . The system for controlling urinary incontinence  100  includes a body  116  of biocompatible material which is configured to fit between the labia minora  40  and the vestibule floor  34  of a vulva  36  of a subject. The body  116 , as in the other embodiments herein, is configured to occlude the urethral meatus  38  of the subject. A first adhesive layer  118  is carried on the body  116 , and a second adhesive layer  120  is carried on the first adhesive layer  118 . The second adhesive layer  120  is configured to be removable from the first adhesive layer  118 . In one embodiment, the second adhesive layer  120  is configured to be removed from the first adhesive layer  118  without causing the first adhesive layer  118  to be removed from the body  116 . In some embodiments, the first adhesive layer  118  is configured to be removable from the body  116 . In other embodiments, the first adhesive layer  118  is configured to be permanently attached to the body  116 . The second adhesive layer  120  includes a ventral adhesive surface  123 , and may include a release liner on its dorsally-oriented side  125  to lessen the force at which the second adhesive layer  120  must be peeled from the first adhesive layer  118 . Any of the removable adhesive layers described in other embodiments herein may incorporate a similar release liner. Further description of release liners is subsequently given in relation to  FIG.  9   . Alternatively, instead of having a release liner, the second adhesive layer  120  may be treated on its dorsally-oriented side  125  to lower its relative tackiness, thus lowering the peel force between the second adhesive layer  120  and the first adhesive layer  118 . 
       FIG.  4    represents an exploded illustration of the system for controlling urinary incontinence  100  shown in  FIG.  5   . In some embodiments, the system for controlling urinary incontinence  100  is packaged and sold in the configuration illustrated in  FIG.  5   . In other embodiments, the body  116 , the first adhesive layer  118 , and the second adhesive layer  120  are each packaged and sold separately. In other embodiments, the body  116 , the first adhesive layer  118 , and the second adhesive layer are packaged separately, but sold together, for example, within a main package. In some embodiments, the body  116  and first adhesive layer  118  are packaged together, and the second adhesive layer  120  is packaged separately. In some embodiments, a user may prepare the system for controlling urinary incontinence  100  shown in  FIG.  2    by placing the second adhesive layer  120  onto the first adhesive layer  118 . 
     In any of these configurations or strategies, the second adhesive layer  118 , as shown in  FIG.  2   , is configured to provide a sealing engagement between the body  116  and the urethral meatus  38 , as described in relation to  FIGS.  1 - 3   . The first adhesive layer  118  is an intermediate layer between the body  116  and the second adhesive layer  120 . At a particular time after the system for controlling urinary incontinence  100  is applied to a user by adhering the second adhesive layer  120  to the vestibule floor  34  and/or urethral meatus  38 , the second adhesive layer  120  may lose some or all of its adhesion or other mechanical properties, for example, by becoming soiled or absorbing liquids, or simply breaking down chemically. The system for controlling urinary incontinence  100  is configured to be removed from the user, by the user or another person, and the second adhesive layer  120  is configured to be removed from the first adhesive layer  118 , by the user or another person. Following removal, the system for controlling urinary incontinence  100  may be replaced on the user, by the user or another person, as the first adhesive layer  116  is configured to provide a sealing engagement between the body  116  and the urethral meatus  38 , as described in relation to  FIGS.  1 - 3   . Prior art devices having a body and only one adhesive layer would have to be discarded once the single adhesive layer was no longer functioning, but the system for controlling urinary incontinence  100  may be reused, and thus has an extended life. With two adhesive layers  118 ,  120 , the life of the system for controlling urinary incontinence  100  may be double that of a prior art single adhesive layer device. The improved efficiency thus can provide a lower cost to the user, a reduced amount of waste from packaging materials, and simpler maintenance and use for the user. 
     In use, the second adhesive layer  120 , is the first of the two adhesive layers  118 ,  120  used for providing a sealing engagement between the body  116  and the urethral meatus  38 . The second adhesive layer  120  also serves to cover and protect the first adhesive layer  118  until the user chooses to remove the system for controlling urinary incontinence  100 , remove the second adhesive layer  120  from the first adhesive layer  118  (thus exposing a formerly protected adhesive surface of the first adhesive layer  118 ) and replace the system for controlling urinary incontinence  100 , such that the first adhesive layer  118  now provides a sealing engagement between the body  116  and the urethral meatus  38 . To remove any possible confusion, in the embodiment of  FIG.  5   , the second adhesive layer  120  is configured to be used (for sealing engagement with the urethral meatus  38  and/or the vestibule floor  34 ) prior to the first adhesive layer. 
     The words “first” and “second” are thus used for purposes of claiming the structure of the system, and are actually opposite of the order of use. However, in an alternative embodiment, it is possible to provide the body  116  and first adhesive layer  118  for use first, and then, after the first adhesive layer  118  loses its adhesion properties with the urethral meatus  38  and/or vestibule floor  34 , to secure a second adhesive layer  120  (having two opposing adhesive surfaces) onto the first adhesive layer  118 . Thus, the first adhesive surface of the second adhesive layer  120  would adhere to the first adhesive layer  118  and the second adhesive surface of the second adhesive layer  120  would be used for sealing engagement with the urethral meatus  38 . 
     Returning to the embodiment of  FIGS.  4  and  5   , the second adhesive layer is shown having a removal feature  122  comprising a tab. Though the removal feature  122  is shown at the posterior end  104  of the system for controlling urinary incontinence  100 , it may alternatively located along any portion of the perimeter  121  of the second adhesive layer  120 , for example, at a location adjacent the anterior end  106 , left lateral end  108 , or right lateral end  110  of the system for controlling urinary incontinence  100 . The removal feature  122  is configured to be engaged by the user, for example by grasping with two opposing fingers, and pulled, in order to peel the second adhesive layer  120  from the first adhesive layer  118 . The first adhesive layer  118  and second adhesive layer  120  may be configured so that the peel force between the second adhesive layer  120  and the first adhesive layer  118  is less than the peel force between the first adhesive layer  118  and the body  116 . This will be described in more detail in relation to  FIGS.  20  and  21   . Because the removal of the second adhesive layer  120  does not remove or damage the first adhesive layer  118 , the system for controlling urinary incontinence  100  will function similarly in its first phase (using the second adhesive layer  120  for adhesion) and its second phase (using the first adhesive layer  118  for adhesion). To remove the second adhesive layer  120  the user may grasp the system for controlling urinary incontinence  100  by opposing fingers of a first hand on, for example, the left lateral end  108  and the right lateral end  110 , and then grasp the removal feature  122  by opposing fingers of the second hand and peel the second adhesive layer  120  from the first adhesive layer  118 /body  116 . The peeling, when the removal feature  122  is used, proceeds from the posterior end  104  to the anterior end  106 . 
     In the embodiment of the system for controlling urinary incontinence  100  of  FIGS.  4 - 5   , including alternative embodiments thereof, the first adhesive layer  118  and/or second adhesive layer  120  may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  116  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
       FIG.  6    illustrates a system for controlling urinary incontinence  130  which, like the embodiment of  FIG.  5   , includes a body  132 , a first adhesive layer  134 , and a second adhesive layer  136 . The system for controlling urinary incontinence  130  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . The body  132  also includes a manipulation member  142  disposed on its dorsal side  112 , and comprising a wall  144  and a pocket  146 . The manipulation member  142  is configured to allow a finger of the user to be inserted into the pocket  146  in order to aid the placement of the system for controlling urinary incontinence  130  in the user, or the removal of the system for controlling urinary incontinence  130  from the user. Like the embodiment of  FIG.  5   , the second adhesive layer  136  includes a tab  138 , but additionally, the first adhesive layer  134  includes a tab  140 . Again, the tabs  138 ,  140  are shown at the posterior end  140  of the system for controlling urinary incontinence  130 , but each or both may be located anywhere around the perimeter. As shown, the tabs  138 ,  140  are adjacent each other, but are slightly staggered or offset, with the tab  138  being closer to the right lateral end  148  of the system for controlling urinary incontinence  130  and the tab  140  being closer to the left lateral end  150  of the system for controlling urinary incontinence  130 . The staggered placement of the tabs  138 ,  140  allows the user, when removing the second adhesive layer  136 , to grasp the tab  138  with opposing fingers of a first hand and to grasp the tab  140  with opposing fingers of a second hand. The user is then able to place a downward force F d  on tab  138  while maintaining an upward force F n  on tab  140 . This allows the user to peel the second adhesive layer  136  from the first adhesive layer  134  without placing any significant peel force between the first adhesive layer  134  and the body  132 . Thus, even in embodiments in which the peel force between the second adhesive layer  136  and the first adhesive layer  134  is not significantly less than the peel force between the first adhesive layer  134  and the body  132 , the risk of inadvertently removing the first adhesive layer  134  from the body  132  is lessened or altogether removed. The peeling, with the tabs  138 ,  140  located as shown, proceeds from the posterior end  152  to the anterior end  154  of the system for controlling urinary incontinence  130 . In some embodiments, the tabs  138 ,  140  may each be a separate color, in order to easily allow the user to differentiate between them. In other embodiments, the adhesive layers  134 ,  136  themselves may each be a separate color. 
     Alternatively, the user may grasp the system for controlling urinary incontinence  130  by opposing fingers of a first hand on, for example, the left lateral end  150  and the right lateral end  148 , and then grasp the tab  138  by opposing fingers of the second hand and peel the second adhesive layer  136  from the first adhesive layer  134 /body  132 . 
     In the embodiment of the system for controlling urinary incontinence  130  of  FIG.  6   , including alternative embodiments thereof, the first adhesive layer  134  and/or second adhesive layer  136  may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  132  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
       FIG.  7    illustrates a system for controlling urinary incontinence  160  comprising a body  162 , a first adhesive layer  164 , a second adhesive layer  166 , and a third adhesive layer  168 . The system for controlling urinary incontinence  160  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . The first adhesive layer  164  is carried on a ventral portion of the body  162 , and is not configured to be removed. A manipulation member  170  comprises a tether, and is secured to the body  162  and/or the first adhesive layer  164 . The manipulation member  170  may be grasped by opposing fingers to remove the system for controlling urinary incontinence  160  from the user via a tensile force which pulls on the anterior end  174 . A scrim  172  or any type of fabric or sheet may be molded into the body  162  and may also be integrated or comingled with the manipulation member  170  in order to secure the manipulation member  170  well with the body  162 . The fabrics or sheets may include woven fabrics or sheets, or in other embodiments, non-woven fabrics or sheets. The third adhesive layer  168  has a tab  176 , and is configured to be used first and removed first. The second adhesive layer  166  has a tab  178 , and is configured to be used second and removed second. The first adhesive layer  164  is configured to be used third, with the system for controlling urinary incontinence  160  configured to be discarded afterwards. Again, thought the tabs  176 ,  178  are shown at the posterior end  180  of the system for controlling urinary incontinence  160 , they may be located at other portions of the perimeter of the system for controlling urinary incontinence  160 . One advantage to being located at the posterior end  180  and not at the anterior end  174 , is that the tabs may be allowed more profile (extension from the body  162 ), as they do not necessarily come in close contact with tissue within the labia minora  40 . A relief  182  may be created in the tabs  176 ,  178 , so that they do not interfere with or cover the vaginal opening  37 . 
     To remove the third adhesive layer  168  from the second adhesive layer  166 , the user grasps tab  178  with a first set of opposing fingers and grasps tab  176  with a second set of opposing fingers and applies opposite forces on the tabs  176 ,  178  to peel the third adhesive layer  168  from the second adhesive layer  166 . This may even be done with a single hand, if the user has enough dexterity, for example using the thumb and index finger as the first pair of opposing fingers, and two or three of the other three fingers to apply the grasping force. To remove the second adhesive layer  166  from the first adhesive layer  164 , the user grasps the body  162  with opposing fingers of a first hand and grasps the tab  178  and pulls on the tab  178  to peel the second adhesive layer  166  from the first adhesive layer  164 . Text  184  can be placed on the tabs, for example, on a dorsal side (as shown), and/or on a ventral side (not visible in  FIG.  7   ) in order to better instruct the user and identify the particular feature. Tab  176  is shown labeled with the text “1” to indicate that tab  176  is grasped when removing the first layer to be removed (third adhesive layer  168 ). Tab  178  is shown labeled with the text “2” to indicate that tab  178  is grasped when removing the second layer to be removed (second adhesive layer  166 ). 
     In the embodiment of the system for controlling urinary incontinence  160  of  FIG.  7    including alternative embodiments thereof, the first adhesive layer  164  and/or second adhesive layer  166  and/or third adhesive layer  168  may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  162  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
       FIG.  8    illustrates a system for controlling urinary incontinence  200  comprising a body  202 , a first adhesive layer  204 , a second adhesive layer  206 , and a third adhesive layer  208 . The system for controlling urinary incontinence  200  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . The third adhesive layer  208  includes a tab  210  containing text  214  with an instruction to the user “REMOVE FIRST.” The second adhesive layer  206  includes a tab  212  containing text  214  with an instruction to the user “REMOVE SECOND.” In alternate embodiments, the test  214  may include an instruction and may also include a mark (e.g., a dot or an “x”) on a particular location of the tab  210 ,  212  that indicates where the user is to grasp the tab  210 ,  212 . The text  214  may also have arrow or other directional indicators which instruct the user which direction to apply a force (e.g., peel force). Either of the third adhesive layer  208  or second adhesive layer  206  may include a composite structure, is seen in the generic composite adhesive layer  216  in  FIG.  9   . The composite adhesive layer  216  includes an adhesive material  218  having an adhesive surface  220  and a liner  222  having a liner surface  224 . The adhesive material  218  and the liner  222  are coupled together at an interface  226 . The interface  226  in configured to hold the adhesive material  218  and liner  222  together and to by resistant to their separation. The adhesive surface  220  of the adhesive material  218  is configured to adhere to the vestibule floor  34  and/or urethral meatus  38 , but may also be configured to adhere to a liner surface  224  of another composite adhesive layer  216 . The liner surface  224  of the liner  222  is configured to be engaged by an adhesive surface (such as the adhesive surface  220  of an adhesive layer  216 ), but is configured to allow the adhesive surface to which it is engaged to be controllably peeled away from it. The liner  222  thus operates as a release liner to further control the peeling of adhesive layers, such as the third adhesive layer  208  and second adhesive layer  206 . The liner  222  may be a non-adhesive, non-tacky material, or may at least be a less-tacky material, so that it may easily be handled without sticking to a user&#39;s fingers. In some embodiments, the tab  210 ,  212  may simply be an extension of the liner  222 , and may even be integral with the liner  222 . The tabs  210 ,  212  and the liner  222  itself may be a non-adhesive, non-tacky material, or may at least be a less-tacky material. Thus, the tabs  210 ,  212  may easily be handled without sticking to a user&#39;s fingers, and the liner  222 , allows controlled peeling of the third adhesive layer  208  from the second adhesive layer  206 . 
     In some embodiments, the body  202  may have a first color and the liner  222  may have a second color, different and distinguishable from the first color, to ease the identification and the removal of the composite adhesive layer  216 . In some embodiments, the body  202  may have a first color and the composite adhesive layer  216  (any part thereof) may have a second color, different and distinguishable from the first color, to ease the identification and the removal of the composite adhesive layer  216 . 
     In some embodiments, the liner  222  comprises a polyolefin, such as a polyethylene or a polypropylene. In some embodiments, the liner  222  comprises a medium-density polyethlene. In some embodiments, the liner  222  comprises polyester, such as polyethylene terephthalate (PET). In other embodiments, the liner  222  may comprise hemp. In some embodiments, the liner  222  may be a solid sheet and in other embodiments, the liner  222  may be a woven structure. In some embodiments, the liner  222  may be configured to be biodegradable, and may comprise cellulose. In some embodiments, the entire composite adhesive layer  216  is biodegradable, and may thus, in some cases, be flushable in a toilet when discarded. 
     In the embodiment of the system for controlling urinary incontinence  200  of  FIG.  8    including alternative embodiments thereof, the first adhesive layer  204  and/or second adhesive layer  206  and/or third adhesive layer  208  may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  202  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
       FIG.  10    illustrates a system for controlling urinary incontinence  230  comprising a body  232 . A perimeter P of the body  232  is shown (dotted line), and forms a general closed arrowhead shape. Tabs  234 ,  236  extend externally of the perimeter P at the posterior end  240 . An additional tab  238  extends externally of the perimeter P at a lateral end  242 . The tabs  234 ,  236 ,  238  may each be attached to a different adhesive layer, or two or more tabs may be attached to a single adhesive layer (e.g., at different locations). The system for controlling urinary incontinence  230  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . 
       FIG.  11    illustrates an adhesive layer  250  which may be used with the embodiments described herein. The adhesive layer  250  includes a sheet  252  of adhesive material having a first end  254  and a second end  256 . The system for controlling urinary incontinence  250  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . At the second end  256  a tab  258  is coupled to the sheet  252  and is configured for grasping, for example, in order to peel the adhesive layer from a system for controlling urinary incontinence. The tab  258  has an internal portion  260  which is an outward extension of the sheet  252  of adhesive material. A first block  262  is attached to the internal portion  260  at a first side, and a second block  264  is attached to the internal portion  260  at a second (opposite) side. The first block  262  includes a first non-adhesive surface  266  configured for non-stick contact by a user. The second block  264  includes a second non-adhesive surface  268  configured for non-stick contact by a user. The two non-adhesive surfaces  266 ,  268  allow a user to easily grasp the tab  258  of the adhesive layer  250  without it sticking to the user&#39;s fingers (or gloves). This facilitates the peeling process of the adhesive layer  250 . 
     An adhesive layer  270 , similar to the adhesive layer  250 , of  FIG.  11    is illustrated in  FIGS.  12  and  13   . The adhesive layer  270  includes a first non-stick surface  272  and a second non-stick surface  274 , which are each coupled to a sheet  276  of adhesive material which comprises the adhesive layer  270 . Each of the non-stick surfaces  272 ,  274  may be formed from a block (Or sheet) having a non-adhesive surface, or the sheet  276  of adhesive material itself may be treated to create (at that particular portion) the non-stick surface  272 ,  274 . The first non-stick surface  272  and second non-stick surface  274  each contain text  278  which includes an instruction (“HOLD HERE”) which also indicates a location for the user to grasp the first non-stick surface  272  and a second non-stick surface  274 . Thus, the first non-stick surface  272  and a second non-stick surface  274  together comprise a tab  282 , however, it is a tab  282  which does not extend externally of the perimeter of the footprint of the sheet  276 . A system for controlling urinary incontinence  280  includes the adhesive layer  270  and a body  284  having a ridge  286 , and a base  288 . The system for controlling urinary incontinence  280  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . The base  288  includes a surface  290  having a first adhesive layer  292 . The adhesive layer  270  acts as the second adhesive layer, and thus is coupled to the first adhesive layer  292 , as shown in  FIG.  13   . A relief  294  is formed in the base  288  (and in some embodiments, in the body  284  also). The relief  294  is located adjacent to the non-stick surface  274  and is large enough to allow at least a portion of a finger to be inserted opposite the non-stick surface  274  to ease the peeling of the (second) adhesive layer  270  from the first adhesive layer  292 . 
     In the embodiment of the system for controlling urinary incontinence  280  of  FIGS.  12  and  13   , including alternative embodiments thereof, the first adhesive layer  292  and/or (second) adhesive layer  270  may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  284  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
       FIG.  14    illustrates an exploded view of a system for controlling urinary incontinence  300  comprising a body  302 , a first adhesive layer  304 , a second adhesive layer  306 , a third adhesive layer  308 , and a fourth adhesive layer  310 . The system for controlling urinary incontinence  300  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . The first adhesive layer  304  is carried on a ventral portion  303  of the body  302 , and may or may not be configured to be removed from the body  302 . In a first embodiment, the system for controlling urinary incontinence  300  is sold separately, for example, the body  302  is sold with the first adhesive layer disposed thereon, while each of the second adhesive layer  306 , third adhesive layer  308 , and fourth adhesive layer  310  is sold separately. In alternative embodiments, the second, third, and fourth adhesive layers  306 ,  308 ,  310  are each identical to each other and represent a single, packaged model (e.g., replacement adhesive layer). However, in the embodiment of  FIGS.  14 - 16   , each of the second, third, and fourth adhesive layers  306 ,  308 ,  310  have a different footprint from each other. Additionally, in the embodiment of  FIGS.  14 - 16   , each of the first, second, third, and fourth adhesive layers  304 ,  306 ,  308 ,  310  have a different footprint from each other. By having different footprints, the adhesive layers provide a staggered overlap which aids a user to grasp a particular adhesive layer and peel it from the adjacent adhesive layer without the need of the adhesive layer to possess a tab that extends substantially from the footprint (perimeter) of the body  302 . Each of the adhesive layers  304 ,  306 ,  308 ,  310 , when it is in its exposed state (with no adhesive layers remaining below it), is configured to provide a sealing engagement between the body  302  and the urethral meatus  38 . The fourth adhesive layer  310  is configured to be removable from the third adhesive layer  308  without detaching the third adhesive layer  308  from the second adhesive layer  306 , without detaching the second adhesive layer  306  from the first adhesive layer  304 , and without detaching the first adhesive layer  304  from the body  302 . The third adhesive layer  308  is configured to be removable from the second adhesive layer  306  without detaching the second adhesive layer  306  from the first adhesive layer  304  and without detaching the first adhesive layer  304  from the body  302 . The second adhesive layer  306  is configured to be removable from the first adhesive layer  304  without detaching the first adhesive layer  304  from the body  302 . 
     The staggered layering of the adhesive layers  304 ,  306 ,  308 ,  310  can be seen in the exploded view of  FIG.  14   , and in the view of the posterior end  312  of the system for controlling urinary incontinence  300  in  FIG.  15    and the view of the right lateral end  314  of the system for controlling urinary incontinence  300  in  FIG.  16   . The anterior end  316  is visible in  FIGS.  14  and  16   , and the left lateral end  318  is visible in  FIGS.  14  and  15   . The fourth adhesive layer  310  has a transverse width W 4  in relation to the longitudinal axis  301 . The third adhesive layer  308  has a transverse width W 3  in relation to the longitudinal axis  301  that is less than the transverse width W 4  of the fourth adhesive layer  310 . The third adhesive layer  308  has a relief area  320  at the left lateral end  318  of the system for controlling urinary incontinence  300 . When it has been determined that the fourth adhesive layer  310  is to be removed (to thus expose the third adhesive layer  308 ), a user grasps the fourth adhesive layer  310  at a left lateral portion  322  which is adjacent the relief area  320 , thus allowing the user to peel the fourth adhesive layer  310  in a left to right manner as well as a posterior to anterior manner. 
     The second adhesive layer  306  has a transverse width W 2  in relation to the longitudinal axis  301 . The second adhesive layer  306  has a transverse width W 2  in relation to the longitudinal axis  301  that is less than the transverse width W 3  of the third adhesive layer  308 . The second adhesive layer  306  has a relief area  324  at the right lateral end  314  of the system for controlling urinary incontinence  300 . When it has been determined that the third adhesive layer  308  is to be removed (to thus expose the second adhesive layer  306 ), a user grasps the third adhesive layer  308  at a right lateral portion  326  which is adjacent the relief area  324 , thus allowing the user to peel the third adhesive layer  308  in a right to left manner as well as a posterior to anterior manner. The first adhesive layer  304  has a relief area  328  at the anterior end  316  of the system for controlling urinary incontinence  300 . When it has been determined that the second adhesive layer  306  is to be removed (to thus expose the first adhesive layer  304 ), a user grasps the second adhesive layer  306  at an anterior portion  330  which is adjacent the relief area  328 , thus allowing the user to peel the second adhesive layer  306  in an anterior to posterior manner. The first adhesive layer  304  has a midline length that is less than a midline length L 2  of the second adhesive layer  306 . 
     In other embodiments, the staggering of the lengths L or widths W of layers may be done in a variety of manners. Adjacent adhesive layers may decrease in widths or lengths or increase in widths or lengths. Over several adhesive layers, the dimensions may sequentially decrease at first, and then sequentially increase. Or, they may sequentially increase at first, and then sequentially decrease. The adhesive layer that is the most ventrally located at any particular moment has in at least one portion of the perimeter of the system for controlling urinary incontinence  300 , an extreme outward dimension that is greater than the extreme outward dimension of the adjacent adhesive layer at that same portion of the perimeter system for controlling urinary incontinence  300 . 
     In the embodiment of the system for controlling urinary incontinence  300  of  FIGS.  14 - 16   , including alternative embodiments thereof, the first adhesive layer  304  and/or second adhesive layer  306  and/or third adhesive layer  308  and/or fourth adhesive layer  310  may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  302  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
       FIG.  17    illustrates a system for controlling urinary incontinence  340  having a longitudinal axis  341 , a body  342 , an anterior end  344 , a posterior end  346 , a left lateral end  348 , a right lateral end  350 , and a longitudinal ridge  352 . The longitudinal ridge  352  comprises a thicker-walled portion  354  (thickness between ventral side  358  and dorsal side  360 ) which is located closer to the posterior end  346  than the anterior end  344 . A thinner-walled portion  356  (thickness between ventral side  358  and dorsal side  360 ), located generally at the anterior end  344 . To remove the system for controlling urinary incontinence  340  from the general area of the vulva  36 , the user grasps the longitudinal ridge  352  (e.g., between opposing fingers) and places a removal force F R1  on the longitudinal ridge  352  thus applying a selective peeling force which begins the peel at the posterior end  346 , and then moves toward the anterior end  344 . 
       FIG.  18    illustrates a system for controlling urinary incontinence  370  having a longitudinal axis  371 , a body  372 , an anterior end  374 , a posterior end  376 , a left lateral end  378 , a right lateral end  380 , and a longitudinal ridge  382 . The longitudinal ridge  382  comprises a thicker-walled portion  384  (thickness between ventral side  388  and dorsal side  390 ) which is located closer to the anterior end  374  than the posterior end  376 . A thinner-walled portion  386  (thickness between ventral side  388  and dorsal side  390 ), located generally at the posterior end  376 . To remove the system for controlling urinary incontinence  370  from the general area of the vulva  36 , the user grasps the longitudinal ridge  382  (e.g., between opposing fingers) and places a removal force F R2  on the longitudinal ridge  382  thus applying a selective peeling force which begins the peel at the anterior end  374 , and then moves toward the posterior end  376 . 
       FIG.  19    illustrates a system for controlling urinary incontinence  400  having a longitudinal axis  401 , a body  402 , an anterior end  404 , a posterior end  406 , a left lateral end  408 , a right lateral end  410 , and a longitudinal ridge  412 . The longitudinal ridge  412  comprises a thicker-walled portion  414  (thickness between ventral side  418  and dorsal side  420 ) which is generally centrally-located between the anterior end  404  and the posterior end  406 . Two thinner-walled portions  416 ,  417  (thickness between ventral side  418  and dorsal side  420 ) are located generally at the posterior end  406  and the anterior end  404 , respectively. To remove the system for controlling urinary incontinence  400  from the general area of the vulva  36 , the user grasps the longitudinal ridge  412  (e.g., between opposing fingers) and places a removal force F R3  on the longitudinal ridge  412  thus applying a generally centrally-located force which is focused at a central area  422 . The systems for controlling urinary incontinence  340 ,  370 ,  400  may each be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . 
     Depending on the specific type of peel or removal mechanics that are desired for a particular embodiment of a system for controlling urinary incontinence one of the particular embodiments of the system for controlling urinary embodiment  340 ,  370 ,  400  of  FIGS.  17 - 19    may be chosen so that the user simply grasps the longitudinal ridge  352 ,  382 ,  412  (or any equivalent structure such as tether, loop, etc. which is located accordingly) and pulls. The chosen mechanics for removal thus happen automatically. In some embodiments, the longitudinal ridge  352 ,  382 ,  412  may be at different location along the longitudinal axis than one or more tabs of one or more adhesive layers, so that the mechanics of the peeling of the adhesive layer(s) is purposely different than the mechanics of the removal of the system for controlling urinary embodiment  340 ,  370 ,  400 . Thus, when the user removes the system for controlling urinary embodiment  340 ,  370 ,  400 , the adhesive layer(s) are less likely to be inadvertently peeled off. In one embodiment, the tabs of the adhesive layers are located near an anterior end of the system for controlling urinary embodiment, while the longitudinal ridge is located near a posterior end. In another embodiment, the tabs of the adhesive layers are located near an posterior end of the system for controlling urinary embodiment, while the longitudinal ridge is located near a anterior end. 
     In the embodiments of the system for controlling urinary incontinence  340 ,  370 ,  400  of  FIGS.  17 - 19   , including alternative embodiments thereof, any adhesive layers may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  342 ,  372 ,  402  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
       FIGS.  20 - 22    illustrate a system for controlling urinary incontinence  430  having a body  432 , an anterior end  434 , a posterior end  436 , and a longitudinal ridge  438  at a dorsal side  440 . The system for controlling urinary incontinence  430  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . A first adhesive layer  444  and a second adhesive layer  446  are disposed at a ventral side  442 , as described with the other embodiment herein. The first adhesive layer  444  comprises an adhesive material  447  and a release liner  449 . The second adhesive layer  446  comprises an adhesive material  451  and a release liner  453 . The release liners  449 ,  453  may comprise materials and characteristics similar to the liner  222  in  FIG.  9   . In some embodiments, a non-removable adhesive layer may be disposed on the body  432  between the body  432  and the first adhesive layer  444 , but in the embodiment of  FIGS.  20 - 22   , and so the first adhesive layer  444  may be removable from a ventral surface on the body  432  or from an intermediate/intervening adhesive layer. A first peel force F P1  is the force required to peel the second adhesive layer  446  from the first adhesive layer  444 , as illustrated in  FIG.  20   . A second peel force F P2  is the force required to peel the first adhesive layer  444  from the body  432  (either from the body  432  alone, or from an intermediate adhesive layer disposed on the body), as illustrated in  FIG.  21   .  FIG.  22    illustrates the system for controlling urinary incontinence  430  in place in a user. The removal force F R  (a normal force required to remove the system for controlling urinary incontinence  430  from the vestibule floor  34  and/or urethral meatus  38 ) causes an equal and opposite tensile force T between the second adhesive layer  446  and the first adhesive layer  444  and also an equal and opposite tensile force T between the first adhesive layer  444  and the body  432 . 
     The materials and/or surface areas of the body  432 , first adhesive layer  444 , and second adhesive layer  446  (and/or the manufacture/processing/fabrication thereof) are controlled so that F P1  is less than F P2 . In some embodiments, F P1  is significantly less than F P2 , so that the purposeful peeling of the second adhesive layer  446  from the first adhesive layer  444  does not cause the first adhesive layer  444  to be peeled from the body  432  (or from any intervening adhesive layer). In some embodiments, F P1  is significantly less than F P2 , so that the purposeful peeling of the second adhesive layer  446  from the first adhesive layer  444  does not cause the first adhesive layer  444  to even begin to be peeled from the body  432  (or from any intervening adhesive layer). 
     The materials and surface areas of the body  432 , the first adhesive layer  4 , and the second adhesive layer  446  are controlled so that the tensile force T 12  at which the second adhesive layer  446  is separated from the first adhesive layer  444  is greater than the removal force F R . The materials and surface areas of the body  432 , the first adhesive layer  4 , and the second adhesive layer  446  are also controlled so that the tensile force T 1B  at which the first adhesive layer  446  is separated from the body  432  (or from any intervening adhesive layer) is greater than the removal force F R . The term “separated from the body” describes wherein a still desired (for current or eventual use) adhesive layer is pulled away enough to damage the system for controlling urinary incontinence  430 , or to stop the system for controlling urinary incontinence  430  from functioning in conjunction with the desired adhesive layer. In some embodiments, the materials, geometry and fabrication of the adhesive layers  444 ,  446  may be controlled such that the removal force F R  (i.e., from the vulva), as previously described in relation to  FIGS.  17 - 19   , is between about one lb f  (pounds-force) and about five lb f . In some embodiments, the adhesive layers  444 ,  446  may be configured such that the removal force F R  is between about one lb f  and about four lb f . In further embodiments, the adhesive layers  444 ,  446  may be configured such that the removal force F R  is between about one lb f  and about three lb f . These ranges have been found to be bearable or comfortable for a large number of users. 
     In the embodiments of the system for controlling urinary incontinence  430  of  FIGS.  20 - 22   , including alternative embodiments thereof, any adhesive layers may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  432  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
     The first peel force F P1 , as described in relation to  FIG.  20   , may be controlled via materials, geometry and fabrication of the adhesive layers  444 ,  446 , such that in some embodiments, it is between about two lb f  and about five lb f , or in other embodiments, about three lb f  and about five lb f , or in other embodiments, three lb f  and about four lb f . Again, the materials, geometry and fabrication of the first adhesive layer  444 , and second adhesive layer  446  are controlled so that F P1  is less than F P2 . 
       FIG.  23    illustrates a system for controlling urinary incontinence  450  having a body  452 , an anterior end  454 , a posterior end  456 , and a longitudinal ridge  458  at a dorsal side  460 . The system for controlling urinary incontinence  450  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . A first adhesive layer  464 , a second adhesive layer  466 , a third adhesive layer  468 , and a fourth adhesive layer  470  are disposed at a ventral side  462 , as described with the other embodiments herein. In some embodiments, a non-removable adhesive layer may be disposed on the body  452  between the body  452  and the first adhesive layer  464 , and so the first adhesive layer  464  may also be configured to be removable from a ventral surface on the body  452  or from an intermediate/intervening adhesive layer. 
     Each of the adhesive layers  464 ,  466 ,  468 ,  470 , when removed by the user, is configured to be peeled from the anterior end  454 . However, the longitudinal ridge  458  is oriented closer to the posterior end  456 , such that, when the system for controlling urinary incontinence  450  is being removed from the user, a removal force F R  placed on the longitudinal ridge  458  creates a removal moment M R  which facilitates both the separation of the system for controlling urinary incontinence  450  from the vestibule floor  34  and urethral meatus  38  of the user and the removal of the system for controlling urinary incontinence  450  from its location between the between the labia minora  40  and the vestibule floor  34  (see  FIGS.  2 - 3   ). Peel force F P4  is the force required to peel the fourth adhesive layer  470  from the third adhesive layer  468 . Peel force F P3  is the force required to peel the third adhesive layer  468  from the second adhesive layer  466 . Peel force F P2  is the force required to peel the second adhesive layer  466  from the first adhesive layer  464 . Peel force F P1  is the force required to peel the first adhesive layer  464  from the body  452  and/or any intervening adhesive layer. In general, the peel force of a lower (more ventral) layer is configured to be lower than the peel force(s) of any of the higher (more dorsal) layers, or lower than the cumulative peel force of all of the higher (more distal) layers as a composite. Thus, the peeling of each adhesive layer, at its chosen time for removal, does not inadvertently remove any of the remaining adhesive layers, either separately or together. 
     The materials and surface areas of the body  452 , first adhesive layer  464 , the second adhesive layer  466 , the third adhesive layer  468 , and the fourth adhesive layer  470  are controlled so that F P4  is less than F P3 . In some embodiments, F P4  is significantly less than F P3 , so that the purposeful peeling of the fourth adhesive layer  470  from the third adhesive layer  468  does not cause the third adhesive layer  468  to be peeled from the body  452  (or from any intervening adhesive layer). In some embodiments, F P4  is significantly less than F P3 , so that the purposeful peeling of the fourth adhesive layer  470  from the third adhesive layer  468  does not cause the third adhesive layer  468  to even begin to be peeled from the body  452  (or from any intervening adhesive layer). 
     The materials and surface areas of the body  452 , first adhesive layer  464 , the second adhesive layer  466 , and the third adhesive layer  468  are controlled so that F P3  is less than F P2 . In some embodiments, F P3  is significantly less than F P2 , so that the purposeful peeling of the third adhesive layer  468  from the second adhesive layer  466  does not cause the second adhesive layer  466  to be peeled from the body  452  (or from any intervening adhesive layer). In some embodiments, F P3  is significantly less than F P2 , so that the purposeful peeling of the third adhesive layer  468  from the second adhesive layer  466  does not cause the second adhesive layer  466  to even begin to be peeled from the body  452  (or from any intervening adhesive layer). 
     The materials and surface areas of the body  452 , first adhesive layer  464 , and the second adhesive layer  466  are controlled so that F P2  is less than F P1 . In some embodiments, F P2  is significantly less than F P1 , so that the purposeful peeling of the second adhesive layer  466  from the first adhesive layer  464  does not cause the first adhesive layer  464  to be peeled from the body  452  (or from any intervening adhesive layer). In some embodiments, F P2  is significantly less than F P1 , so that the purposeful peeling of the second adhesive layer  466  from the first adhesive layer  464  does not cause the first adhesive layer  464  to even begin to be peeled from the body  452  (or from any intervening adhesive layer). 
     In the embodiments of the system for controlling urinary incontinence  450  of  FIG.  23   , including alternative embodiments thereof, any adhesive layers may comprise one or more of the following: a hydrogel, such as Poly(2-hydroxyethyl methacrylate) (pHEMA), or a silicone hydrogel, such as a water gradient silicone hydrogel. The body  452  may comprise a foam or a silicone hydrogel, such as a water gradient silicone hydrogel. 
     Prior art female urinary continence devices having a single adhesive layer tend to require removal, discard, and replacement of the entire device around four times each day. One common reason for the relatively short usage life of each of these devices is degradation of the adhesive. The system for controlling urinary incontinence  450  of  FIG.  23   , even if no further improvements were made on the durability of the adhesive, has up to a four-time (4 X) improvement in durability, thus allowing a single device to be used effectively for an entire day, and even longer. Based on the improved durability, the system for controlling urinary incontinence  450  may be configured to be discarded after about twelve to thirty-six hours of use. In some embodiments, the system for controlling urinary incontinence  450  may be configured to be discarded after about eighteen to thirty hours of use. In some embodiments, the system for controlling urinary incontinence  450  may be configured to be discarded after about twenty-one to twenty-seven hours of use. 
       FIGS.  24 - 25    illustrate a system for controlling urinary incontinence  500  having a body  502 , an anterior end  504 , a posterior end  506 , a left lateral end  508 , a right lateral end  510 , a ventral side  516 , and a resilient manipulation member  512  carried on a dorsal side  514 . The system for controlling urinary incontinence  500  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1   . The manipulation member  512  may comprise a flexible and/or foldable sheet  518  having a first end  520  which is coupled to the body  502 . The manipulation member  512  extends from the dorsal side  514  of the system for controlling urinary incontinence  500  and terminates at a free second end  522 . The system for controlling urinary incontinence  500  has a lower profile configuration ( FIG.  24   ) wherein manipulation member  512  lies along the dorsal side  514  of the body  502 . The system for controlling urinary incontinence  500  also has an expanded profile configuration ( FIG.  25   ) wherein the second end  522  is displaced from the dorsal side  514  of the body  502 , as a fin. A first portion  526 , on one side of a midline  528  of the manipulation member  512 , may be secured to the body  502  by adhesives, epoxy, heat fusing, or other known manners, while a second portion  524  is left unsecured. In one embodiment, when removing the system for controlling urinary incontinence  500 , a user may grasp the manipulation member  512  (for example, with opposing fingers) at an engagement site  524  and apply a tensile force FT, which moves the second portion  524  into a position generally perpendicular to a plane approximating the dorsal side  514  of the body  502 . The system for controlling urinary incontinence  500  thus has a manipulation member  512  that functions similarly to the longitudinal ridge  26 ,  286 ,  352 ,  382 ,  412 ,  438 ,  458  of other embodiments described herein, but allows for a lower profile ( FIG.  24   ) when in place in the user. 
     The sheet  518  may comprise a fabric or other structures, both woven and non-woven. A woven structure may serve to increase surface area to improve binding or bonding for the structures together. The first portion  526  of the manipulation member  512  may be incorporated into the body  502  or even into a (non-removable) adhesive layer. The sheet  518  may be laminated or composite and may include an intermediate “tie” layer which is incorporated into the body  512 . In some embodiments, the sheet  518  comprises polyester, for example, a non-woven Sontara® 8000 series polyester, supplied by E. I. Du Pont de Nemours and Company Corporation, Wilmington, Del., USA. In some embodiments, the sheet  518  comprises polyethylene, for example, an embossed non-woven polyethylene such as Vancive® 5725P, supplied by Avery Dennison Corporation, Pasadena Calif., USA. In some embodiments, the sheet  518  comprises a polyethylene foam, for example, as supplied by Sekisui, as described herein. In some embodiments, the sheet  518  comprises a non-woven blend of cellulose and polyester. In some embodiments, the sheet  518  comprises collagen. In some embodiments, the manipulation member  512  may be scored or creased along the midline  528 , such that the second portion  524  extends substantially perpendicular to the dorsal side  514  of the body  502 . In some embodiments, the system for controlling urinary incontinence  500  may include removable adhesive layers, such as those described herein. 
       FIGS.  26 - 27    illustrate a system for controlling urinary incontinence  530  having a body  532 , an anterior end  534 , a posterior end  536 , a left lateral end  538 , a right lateral end  540 , a ventral side  546 , and a manipulation member  542  carried on a dorsal side  544 . The system for controlling urinary incontinence  530  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1    or the system for controlling urinary incontinence  500  of  FIG.  24   . The system for controlling urinary incontinence  530  includes a first adhesive surface  548  carried on a ventral surface  554  the body  532 , a first removable adhesive layer  550  and second removable adhesive layer  552 . The first removable adhesive layer  552  includes a second adhesive surface  556 , and the second removable adhesive layer  552  includes a third adhesive surface  558 . The third surface  558  of the second removable adhesive layer  552  is configured to be used initially by the user. The second removable adhesive layer  552  is configured to be removed from the first removable adhesive layer  550 , for example, when the adhesion of the third adhesive surface  558  is no longer sufficient or desirable (e.g., no longer is capable of producing desired removal forces). The second adhesive surface  556  of the first removable adhesive layer  550  is then configured to be used by the user. The first removable adhesive layer  550  is configured to subsequently be removed from the first adhesive surface  548 , for example, when the adhesion of the second adhesive surface  556  is no longer sufficient or desirable. The first adhesive surface  548  is then configured to be used by the user. The body  532  having the first adhesive surface  548  may then be discarded when the first adhesive surface  548  is no longer sufficient or desirable. Each of the first and second removable adhesive layers  550 ,  552  may include a liner  560 ,  562 , for example, to provide a controlled peel force. 
     The manipulation member  542  has a fin-shape, and is formed from a single sheet  564  having a first lateral end  566  and a second lateral end  568 . A first portion  570  of the sheet  564  is secured to the body  532  left of a longitudinal axis  574  and a second portion  572  of the sheet  564  is secured to the body  532  right of the longitudinal axis  574 . Each of the portions  570 ,  572  may be secured to the body  532  by adhesive, epoxy, or may be heat formed or molded into the body  532 . In some embodiments, the portions  570 ,  572  may be woven into the body  532 , or into a woven layer that is embedded within the body  532 . A central portion  576  of the sheet  564  includes a left side  578  and a right side  580 , which may be formed by folds, such as base folds  582 ,  584  and an intermediate fold  586 . In other embodiments, one or more of the folds  582 ,  584 ,  586  may include scoring on one or more face of the sheet  564 , which may aid the foldability. In other embodiments, one or more of the folds  582 ,  584 ,  586  may include intermittent longitudinal (broken) cuts through the sheet  564 , which may aid the foldability. In some embodiments, in place of the folds  582 ,  584 ,  586  may instead by small radius curves (e.g., about 90°) which are formed into the sheet  564 . 
     With the first and second portions  570 ,  572  of the sheet  564  secured to the body  532 , the left side  578  and right side  580  of the central portion  576  of the sheet  564  need not be secured to each other by any means, (e.g., in the space  588  between them), as they are integral to each other, both being part of the sheet  564 . However, in some embodiments, an adhesive or epoxy may be placed within the space  588  to either further secure the left side  578  and right side  580  of the central portion  576  and/or to stiffen the central portion  576 . In some embodiments, the central portion  576  may purposely be left flexible so that it may be folded to one or the other side of the body  532 . Or, in other embodiments, if the space  588  is non-bonded, the central portion  576  may be opened and folded along lines  533  (on each side) to bring the fold  586  straight down to toward the longitudinal axis  574  of the body  532 . However, like the ridge  26  of the body  12  in  FIG.  1   , the manipulation member  542  provided by the central portion  576  is configured to comfortably reside between the labia minora  40  ( FIG.  3   ) when worn (e.g., when in place) on the user. By grasping the manipulation member  542  with two opposing fingers, the user may apply a removal force in either a dorsal direction, a posterior direction, or a combination of both, or may apply a removal moment, for some peeling effect, as described in relation to  FIG.  23   . Though one particular shape is displayed in  FIG.  26   , a number of shapes are contemplated for the manipulation member  542 , including shapes similar to, but not limited to, the shapes of the longitudinal ridges  352 ,  382 ,  412  in  FIGS.  17 - 19   . The sheet  564 , includes contours which, when secured to the body  532 , match or follow the contouring of the body  532 . For example, the anterior portion of the secured sheet  564  has a smaller width than the posterior portion, and tapers anteriorly, much like the body  532 . By the use of a single sheet  564  to form the manipulation member  542 , the body  532  need not be molded in a more complex shape (as in  FIG.  1   ), and may have a simpler, more two-dimensional form. In some embodiments, the body  532  need not be molded at all, and may instead be cut from sheet material or even from foam tape. More examples will be provided in the following embodiments. 
       FIG.  28    illustrates a system for controlling urinary incontinence  600  having a body  602 , an anterior end  604 , a posterior end  606 , a left lateral end  608 , a right lateral end  610 , a ventral side  616 , and a manipulation member  612  carried on a dorsal side  614 . The system for controlling urinary incontinence  600  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1    or the system for controlling urinary incontinence  500  of  FIG.  24   . The body  602  may comprise a foam base which is cut from a sheet of material, and includes one or more adhesive layers  618  disposed on the ventral side  616 . The system for controlling urinary incontinence  600  is shown in  FIG.  28    in its packaged configuration, and has a removable protective sheet  620  covering the adhesive layer  618 . The protective sheet  620  may comprise a paper or cardboard, or a polyester sheet. The protective sheet  620  may be coated with a release coating to ease removal from the adhesive layer  618 . Any of the embodiments described herein may include a protective sheet similar to the protective sheet  620  for covering the most ventral adhesive surface while packaged and prior to use. Though only one adhesive layer  618  is shown in  FIG.  28   , the system for controlling urinary incontinence  600  may include multiple removable adhesive layers, as in other embodiments herein. The protective sheet  620  is shown having dimensions that are somewhat larger than the dimensions of the body  602 , this allowing access for one or more of the ends to be grasped for peeling the protective sheet  620  off from the adhesive layer  618 . The protective sheet  620  has a projection  622 , or tab, at its anterior end to aid in this purpose. 
     The manipulation member  612  is formed from a single sheet  624  having a first lateral end  626  and a second lateral end  628 . A first portion  630  of the sheet  624  is secured to the body  602  at one side and a second portion  632  (e.g., a “fin”) is configured for grasping. The first portion  630  may be secured to the body  602  by adhesive, epoxy, or may be heat formed or molded into the body  602 . In some embodiments, the first portion  630  may be woven into the body  602 , or into a woven layer that is embedded within the body  602 . 
     In  FIG.  29   , the system for controlling urinary incontinence  600  is in place adjacent the vestibule  34  of a user. During removal, the user grasps the second portion  632  between opposing fingers and pulls, placing a tensile force T on the second portion  632 , and a removal force on the system for controlling urinary incontinence  600 , thus separating the adhesive layer  618  from the urethral meatus  38  and/or the vestibule  34 . The tensile force T is transferred to a region in the vicinity of a mid-line  634  adjacent a fold  636  in the sheet  624 . The system for controlling urinary incontinence  600  is constructed from simple, sheet materials, including the body  602 , the adhesive layer(s)  618 , the sheet  624  comprising the manipulation member  612 , and the removable protective sheet  620 , thus the manufacturing process is simplified. Alternatively, the one or more adhesive layers may be coated onto the body  602 , instead of being sheet material. The manufacturing steps may include only a) procuring a particular sheet material, b) cutting the sheet material to a desired shape, c) attaching one cut sheet shape to another cut sheet shape, and d) adding adhesive to one or more of the sheets. Thus, the system for controlling urinary incontinence  600  may be efficiently mass-produced. 
       FIGS.  30 - 31    illustrate a system for controlling urinary incontinence  640  having a body  642 , an anterior end  644 , a posterior end  646 , a left lateral end  648 , a right lateral end  650 , a ventral side  656 , and a manipulation member  652  carried on a dorsal side  644 . The system for controlling urinary incontinence  640  may be constructed from any of the materials described in relation to the female urinary incontinence device  10  of  FIG.  1    or the system for controlling urinary incontinence  500  of  FIG.  24   . The body  642  may comprise a foam base which is cut from a sheet of material, and includes one or more adhesive layers  658  (removable and/or non-removable) disposed on the ventral side  656 . The system for controlling urinary incontinence  640  is shown in  FIG.  30    in an exploded view and in  FIG.  31    in its packaged configuration, and is packaged or supplied with a removable protective sheet  660  covering the adhesive layer(s)  658 . The protective sheet  660  may comprise a paper or cardboard, or a polyester sheet. The protective sheet  660  may be coated with a coating to ease removal from the adhesive layer  658 . Though only one adhesive layer  658  is shown in  FIGS.  30 - 31   , the system for controlling urinary incontinence  640  may include multiple removable adhesive layers, as in other embodiments herein. 
     The system for controlling urinary incontinence  640  of  FIGS.  30 - 31   , like the system for controlling urinary incontinence  600  of  FIGS.  28 - 29   , can be manufactured in a simple and efficient manner using predominantly sheet materials. The manipulation member  652 , however, comprises two sheets instead of one. A first sheet  662  has a first end  664  and a second end  666 , and a first portion  668  and a second portion  670 , separated by a fold  672 . The first portion  668  of the first sheet  662  is secured to the body  642  at a first side and the second portion  670  (e.g., a “fin”) is configured for grasping, though only on one (external, lateral) side. The first portion  668  may be secured to the body  642  by adhesive, epoxy, or may be heat formed or molded into the body  642 . In some embodiments, the first portion  668  may be woven into the body  642 , or into a woven layer that is embedded within the body  642 . A second sheet  674  has a first end  676  and a second end  678 , and a first portion  680  and a second portion  682 , separated by a fold  684 . The first portion  680  of the second sheet  674  is secured to the body  642  at a second side (opposite the first side) and the second portion  682  (e.g., a “fin”) is configured for grasping, though only on one (external, lateral) side, as the second portion  682  of the second sheet  674  is configured to couple to the second portion  670  of the first sheet  662 . The first portion  680  of the second sheet  674  may be secured to the body  642  by adhesive, epoxy, or may be heat formed or molded into the body  642 . In some embodiments, the first portion  680  may be woven into the body  642 , or into a woven layer that is embedded within the body  642 . The second portion  682  of the second sheet  674  may be secured to the second portion  670  of the first sheet  662  using adhesive, hot melt or epoxy, or by thermal securement, or even by fasteners (staples, sewing, suturing, riveting, etc.). In the case of adhesive, hot melt or epoxy joining, the material used to adhere the two portions may be applied between the two portions on one or both of the internal faces  686  (only one is visible in  FIG.  30   ). In  FIG.  31   , the first portion  668  is shown secured at a portion of the body  642  toward the left lateral end  648 , and the first portion  680  is shown secured at a portion of the body  642  toward the right lateral end  650 . As previously described, the materials of the body  502 ,  532 ,  602 ,  642  of any of the embodiments of  FIGS.  24 - 31    may comprise foam materials such as HYPOL 2002 or HYPOL 6000, polyvinyl chloride foam, or polyolefin foam. In some embodiments, a polyvinyl chloride foam may be utilized, such as Gaska® tape supplied by Gaska Tape, Inc., Elkhart, Ind., USA, and may have a density of between about 80 kg/m 3  and about 160 kg/m 3 , or in other embodiments between about 95 kg/m 3  and about 130 kg/m 3 , or in other embodiments, about 112 kg/m 3 . In some embodiments, a polyolefin foam may be utilized, such as Softlon™ or Volara® foams, supplied by Sekisui Voltek LLC Corporation, Lawrence, Mass., USA. 
     Additionally, and as previously described, the materials of the sheets  518 ,  564 ,  624 ,  662 ,  674  may comprise polyester, for example, a non-woven Sontara® 8000 series polyester, supplied by E. I. Du Pont de Nemours and Company Corporation, Wilmington, Del., USA, or a polyethylene, for example, an embossed non-woven polyethylene such as Vancive® 5725P, supplied by Avery Dennison Corporation, Pasadena Calif., USA, or a polyethylene foam, for example, as supplied by Sekisui, as described herein, or a non-woven blend of cellulose and polyester. The body  502 ,  532 ,  602 ,  642  or sheet  518 ,  564 ,  624 ,  662 ,  674  may in some embodiments be die-cut, thus further increasing the efficiency of producing them. 
     Any of the embodiments of the system for controlling urinary incontinence described herein may additionally comprise an anti-bacterial coating, to further provide a system which may remain on the user for a prolonged amount of time. 
     From the foregoing, the features of the present invention will be readily appreciated. The incontinence device in accordance with the present invention provides effective management of female urinary incontinence, such as stress incontinence, without the inconvenience and discomfort associated with prior art urine collection devices and absorbent pads. The present invention is easy to use and comfortable to wear. It is easily shaped and sized to fit each individual user&#39;s anatomy with optimum effectiveness and comfort. Easily and inexpensively manufactured, the present invention can be made as a disposable item. 
     While embodiments have been shown and described, various modifications may be made without departing from the scope of the inventive concepts disclosed herein.