Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women

Official Title
-----------------
A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence

Conditions
-----------------
Urinary Stress Incontinence

Intervention / Treatment
-----------------
* Device: transvaginal placebo device
* Device: transvaginal electrical stimulation device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >=18 years old Signed informed consent form Women with urinary stress incontinence defined as follow Involuntary loss of urine during increased abdominal pressure. In case of mix urinary incontinence (i.e., stress urinary incontinence associated to urge urinary incontinence) the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogic scale is higher for stress incontinence than for urge incontinence symptoms. closure pressure between 10 and 60 cm H2O the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogical scale is higher than 40/100 Patients never treated with transvaginal electrical stimulation Vaginal muscle strength less than 3/5 on the muscular testing Positive Pad test (>2 g of leakage measure by pad test with standardised bladder volume) Exclusion Criteria: Patient refusing to sign the consent form patient unable to understand or follow the protocol inadequate cognitive ability patient participating in another research protocol within the 3 previous months pregnancy women with no contraception pacemaker history of recent (< 1 year) transvaginal electrical stimulation treatment at home urinary incontinence other than stress incontinence neurological disease permanent metrorrhagia ongoing urinary tract infections vaginal prolapse > 2 untreated atrophic vaginitis history of surgical treatment for urinary stress incontinence or genital prolapse recent pelvic surgery (<6 months) anatomic defect that preclude the use of the device genitourinary cancer or colic cancer patient already treated for urinary stress incontinence Recent oestrogen treatment (less than 3 weeks)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks | Device: transvaginal electrical stimulation device<br>* Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks<br>|
| Placebo Comparator: 2<br>Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks | Device: transvaginal placebo device<br>* Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks |  | 8 weeks | 
| Assessment of the discomfort linked to urinary stress incontinence occurring the previous week assessed on a 0 - 100 visual analog scale at 8 weeks |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic investigation |  | 4 and 8 weeks | 
| Standardised Pad test |  | 4 and 8 weeks | 
| Number of severe urinary stress incontinence episodes |  | 4 and 8 weeks | 
| Number of sanitary napkins used |  | 4 and 8 weeks | 
| Leakage index |  | 4 and 8 weeks | 
| Subjective appreciation of patients |  | 4 and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary stress incontinence, urinary stress incontinence in women