Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
NCT ID: NCT00762593
Last Updated: 2008-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2006-01-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks
transvaginal electrical stimulation device
Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
2
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
transvaginal placebo device
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
Interventions
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transvaginal placebo device
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
transvaginal electrical stimulation device
Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
FEMALE
No
Sponsors
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Akontis
INDUSTRY
Responsible Party
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Akontis
Locations
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Centre européen d'explorations gynécologiques
Paris, , France
Countries
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Other Identifiers
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KEAT F1
Identifier Type: -
Identifier Source: org_study_id