The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The following clinical trial investigates the efficacy of transvaginal radiofrequency in the physiotherapy treatment of stress urinary incontinence (SUI). The treatment compares transvaginal radiofrequency with pelvic floor muscle training (PFMT) and PFMT alone. The present study is a randomized controlled trial with double blinding (evaluator and patients). The objective is to evaluate what radiofrequency can provide in the improving of the quality of life, symptoms and pelvic floor muscle strength of patients with SUI. The reason for the combination with PFMT, is that it is the golden standard treatment in pelvic floor rehabilitation and SUI improvement.

Detailed Description
-----------------
Urinary incontinence (UI) is a health burden for more than 200 million people in the world. 34% of women over the age of 40 experience or have already experienced some significant experience with UI, thus affecting their health-related quality of life (QoHR). SUI is endowed with a complex and multifactorial pathophysiology, generally involving the pelvic floor musculature and adjacent collagen-dependent tissues that help in support. According to the literature, there are two clearly described mechanisms: The loss of urethral support, of the anterior vaginal wall, transforming into urethral hypermobility. Deficiency of urethral closure, such as rotational descent of the proximal part of the urethra, of the pubourethral ligament, with loss of internal urethral integrity. The pelvic floor musculature plays an important role in helping the urethral support, during voluntary contraction. If the muscles are weak, urine loss is greater. RF is an electrophysical and medical technique that generates tissue heating for therapeutic purposes. This technology uses electromagnetic RF fields with frequencies between 434 and 925 MHz, these forming part of the techniques classified as high frequency. The increases in temperature can reach 41.5ºC to 45ºC, according to some studies, and in another reaching 50ºC, acting at 6 and 8 cm3 depth, and generating biological effects on the skin and in the deeper layers. It is known that RF promotes angiogenesis and increases local vascularization, stimulating collagen and elastin, resulting in changes in the helical structure of collagen, due to the denaturation and restructuring of its fibers. Changing the nature of connective tissues. Investigators will make use of the non-ablative resistive RF mode, which does not have the capacity to section, but does have cell stimulation through superficial application on the skin, generating anti-inflammatory effects at the physiological level and collagen contraction, as an effect of short duration, and the stimulation of collagen synthesis or neocollagenesis thanks to the inflammation of the fibroblasts, to repair the damage present, as a long-lasting effect. Which would be interesting, because the pelvic floor is formed in its great majority by connective tissue and this would help to regenerate the tissue. Treatment with this technology has not been sufficiently investigated in the intravaginal treatment of the pelvic floor. Previous studies lead to transurethral medical treatments that require local anesthesia, and the pathologies treated are the different types of urinary incontinence (stress, urgency, and mixed) and vaginal laxity. However, from the transvaginal approach the investigators found few studies.

Official Title
-----------------
The Effectiveness of Transvaginal Radiofrequency and Pelvic Floor Muscle Training Compared to Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: a Double-blind Randomized Controlled Trial

Conditions
-----------------
Urinary Incontinence,Stress, Pelvic Floor Disorders, Urinary Incontinence, Pelvic Floor Muscle Weakness

Intervention / Treatment
-----------------
* Device: RF + PFMT
* Other: PFMT + Placebo RF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 20 - 75 years Previously diagnosed SUI through assessment and questionnaires. PAD Test of 1h with > or = 1gr of urine loss. Urine losses in the last week. Nulliparous and multiparous. Exclusion Criteria: Women > 75 years. Another type of urinary incontinence, urge or mixed. Difficulty urinating Hematuria Pregnancy Patients with any type of cancer or with a personal history of it. Previous surgeries for the treatment of SUI Gynecological surgeries (hysterectomy, containment mesh for different prolapses). Neurological and cognitive problems. Injury to the spinal cord, lower limbs or pelvis. Grade II, III or IV pelvic organ prolapse. Vaginal or urinary infection. Drugs: Antimuscarinics (oxybutinin) Toterodine Trospium Solifenacin Darifenacin Fesoterodine Atropine Anticholinergics Antidepressants: Duloxetine Imipramine Estrogens Botulinum Toxin Alpha-adrenergic agonists Ephedrine Pseudoephedrine Antidiuretics (desmopressin)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The present study is a double-blind randomized clinical trial. Two groups are located, case group and placebo group. The total number of sessions will be 18 sessions per patient, divided into three sessions per week for a total of six weeks. These sessions last one hour, with a net treatment time of 40 minutes in the supine position. The vaginal probe is inserted into the cavity using a lubricant suitable for intracavitary use and RF, the device is turned on, while the RF is applied, pelvic floor contractions are performed guided by the physiotherapist 2 (Marta Martínez Colmenar) . The evaluations before and after the study will be carried out by the physiotherapist 1 (Yasmin Er Rabiai Boudallaa) who is blinded to group allocation. All participants will be assessed before, after six weeks and 6 months after the start of the study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RF + PFMT<br>The participants recieve 18 sessions of radiofrequency (RF) and pelvic floor muscle training (PFMT), divided into three sessions per week for a total of six weeks, with a net treatment time of 40 minutes, each one. | Device: RF + PFMT<br>* During each session the patient is lying face up, with knees bent and feet resting on the stretcher. Then, the vaginal probe is introduced into the cavity using a lubricant suitable for intracavitary use and radiofrequency. The device is started at 15% intensity and adapting to a 10-point Likert scale, at point 3 or 4 of intensity. At the same time that the radiofrequency is applied, pelvic floor contractions are performed guided by the physiotherapist, and these contractions are three: 10 fast contractions of one second each, with 10 seconds of rest. 5 seconds of sustained contraction and 10 seconds of rest. 10 seconds of contraction maintained with 10 seconds of rest. The contraction maintenance time will be adapted to what each woman can keep the pelvic floor contracted, with a view to the goal being to complete these exercises cyclically during the entire session.<br>* Other names: INDIBA Activ CT9 SN: 19A150410;|
| Placebo Comparator: PFMT<br>The participants recieve 18 sessions of no radiofrequency (RF) and pelvic floor muscle training (PFMT), divided into three sessions per week for a total of six weeks, with a net treatment time of 40 minutes, each one. The RF device is started, but in this case, the program does not work or apply radiofrequency to the patients. | Other: PFMT + Placebo RF<br>* The intervention is exactly the same as the group RF + PFMT, unlike the non-functioning of the RF in the patients belonging to this group. The patient is lying face up, with knees bent and feet resting on the stretcher. Then, the vaginal probe is introduced into the cavity using a lubricant suitable for intracavitary use and radiofrequency, the device is started at 15% intensity, but in this case, the program does not work or apply radiofrequency to the patients. At the same time, that the radiofrequency's probe is applied, pelvic floor contractions are performed guided by the physiotherapist, and these contractions are the three named in the Radiofrequency + PFMT. The contraction maintenance time will be adapted to what each woman can keep the pelvic floor contracted, with a view to the goal being to complete these exercises cyclically during the entire session.<br>* Other names: INDIBA Activ CT9 SN: 19A150410;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the ICIQ-SF scale before, after and six months after treatment in both groups. | ICIQ-SF: International Consultation on Incontinence Questionnaire, short form. The minimum score is 0, and the maximum is 21. Where 0 is the absence of urinary incontinence and everything valued above 0 is a symptom of urinary incontinence. The higher the value, the worse the incontinence. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 
| The change of signs, symptoms and impact of pelvic floor dysfunction (PFDI-20) between reviews (before, after and at six months of treatment in both groups). | PFDI-20 : Pelvic Floor Distress Inventory Questionnaire - 20. It has 20 questions that are in turn divided into three symptomatic scales. The minimum value is 0, and the maximum is 300, which is the result of the sum of the total of the three subscales of 100 points of maximum value. This scale, the higher the value, the greater the pelvic floor dysfunction. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 
| The change of signs, symptoms and impact of pelvic floor dysfunction (PFIQ-7) between reviews (before, after and at six months of treatment in both groups) | PFIQ-7 has 7 questions for each subscale, which are three in total. The minimum value is 0, and the maximum is 300, which is the result of the sum of the total of the three subscales of 100 points of maximum value. This scale, the higher the value, the greater the pelvic floor dysfunction. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in maximum and average strength of the pelvic floor before, after and six months after treatment in both groups. . | The maximum and average muscle strength is the value offered by the pelvimetry at the vaginal level, resulting from three submaximal contractions requested from the woman. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 
| Changes in muscle tone before, after and six months after treatment in both groups. | Muscle tone is measured with a pelvimeter, which is inserted vaginally and the patient in the supine position and triple flexion of the lower limbs, relaxes and we take the base measurement, resulting from the subtraction of the result obtained minus 170mmHg of base. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 
| Changes in sexual function (FSFI) before, after and six months after treatment in both groups. | FSFI: Female Sexual Function Index. The minimum value is 2, and the maximum is 36, which is the result of the sum of the results of each domain, which are 6 in total, with a maximum value of 6 points each. This scale the higher the value, the better sexual function. It consists of 19 questions, divided into subgroups according to the symptom to be studied: desire, arousal, lubrication, orgasm, satisfaction, and pain. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 
| Check the level of physical activity measured with the GPAQ scale, in both groups, before, after and at six months. | GPAQ: global physical activity questionnaire. The GPAQ measures how many MET-min of physical activity is engaged during a typical week. The MET-min per week obtained from the GPAQ is a scale-type variable. Moderate- intensity physical activity corresponds to 4 MET/min, and vigorous-intensity physical activity corresponds to 8 MET/min.[6] During the calculation of weekly total MET-min, the durations of each type of physical activity are multiplied by these coefficients. The minimum value is 0 and the maximum is 3000 MET-min. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 
| Changes in the Pad Test 1h before, after and six months after treatment in both groups. | Indications are given for one consecutive hour using a pad that will be given to the researcher, as well as a pad of the same model to weigh the difference obtained. The indications range from the intake of 500 ml of water, to various abdominal hyperpressure exercises. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 
| Changes in Pelvic Muscle Excersice Self-Efficacy (Broome scale) before, after and six months after treatment in both groups. | Evaluates the perception and safety of patients in knowing how to contract the pelvic floor in different situations of daily life and their degree of confidence in them in the face of abdominal hyperpressure. The minimum value is 0 and the maximum is 100 in both subscales. The higher the value, the greater the awareness and confidence in the pelvic floor contractions. | Before treatment, six weeks of treatment, and 6 months assessments were required. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary loss, Pelvic floor dysfunctions, Women, Pelvic floor muscle training, Indiba Therapy, Physiotherapy