KEAT F1: Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks |
Device: transvaginal electrical stimulation device
Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
|
| Placebo Comparator: 2 Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks |
Device: transvaginal placebo device
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
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
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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
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Patients never treated with transvaginal electrical stimulation
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Vaginal muscle strength less than 3/5 on the muscular testing
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Positive Pad test (>2 g of leakage measure by pad test with standardised bladder volume)
Exclusion Criteria:
-
Patient refusing to sign the consent form
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patient unable to understand or follow the protocol
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inadequate cognitive ability
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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
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urinary incontinence other than stress incontinence
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neurological disease
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permanent metrorrhagia
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ongoing urinary tract infections
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vaginal prolapse > 2
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untreated atrophic vaginitis
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history of surgical treatment for urinary stress incontinence or genital prolapse
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recent pelvic surgery (<6 months)
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anatomic defect that preclude the use of the device
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genitourinary cancer or colic cancer
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patient already treated for urinary stress incontinence
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Recent oestrogen treatment (less than 3 weeks)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre européen d'explorations gynécologiques | Paris | France | 75005 |
Sponsors and Collaborators
- Akontis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KEAT F1