Urinary Stress Incontinence
Conditions
Keywords
urinary stress incontinence, urinary stress incontinence in women
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
Interventions
DEVICEtransvaginal placebo device
Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks
DEVICEtransvaginal electrical stimulation device
Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
Sponsors
Akontis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Number of severe urinary stress incontinence episodes | 4 and 8 weeks |
| Number of sanitary napkins used | 4 and 8 weeks |
| Urodynamic investigation | 4 and 8 weeks |
| Subjective appreciation of patients | 4 and 8 weeks |
| Leakage index | 4 and 8 weeks |
| Standardised Pad test | 4 and 8 weeks |
Countries
France
Outcome results
None listed