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

Phase 2

• Conditions: Urinary Stress Incontinence
• Interventions: Device: transvaginal electrical stimulation device; Device: transvaginal placebo device

• Registration Number: NCT00762593
• Lead Sponsor: Akontis

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Status Verified: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Last Update Submitted: 2008-10-16
• Last Update Posted: 2008-10-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	transvaginal electrical stimulation device	transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks
2	transvaginal placebo device	Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Centre européen d'explorations gynécologiques; 🇫🇷 Paris, France