Clinical trial NCT00762593: Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Official title: A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urinary Stress Incontinence
Keywords: urinary stress incontinence
urinary stress incontinence in women
Lead sponsor: Akontis
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks
timeFrame: 8 weeks
measure: Assessment of the discomfort linked to urinary stress incontinence occurring the previous week assessed on a 0 - 100 visual analog scale at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Urodynamic investigation
timeFrame: 4 and 8 weeks
measure: Standardised Pad test
timeFrame: 4 and 8 weeks
measure: Number of severe urinary stress incontinence episodes
timeFrame: 4 and 8 weeks
measure: Number of sanitary napkins used
timeFrame: 4 and 8 weeks
measure: Leakage index
timeFrame: 4 and 8 weeks
measure: Subjective appreciation of patients
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre européen d'explorations gynécologiques
Study officials:
References: