Overview

This trial is active, not recruiting.

Condition urinary stress incontinence
Treatments transvaginal placebo device, transvaginal electrical stimulation device
Phase phase 2
Sponsor Akontis
Start date January 2006
End date October 2008
Trial size 150 participants
Trial identifier NCT00762593, KEAT F1

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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
(Placebo Comparator)
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

Primary Outcomes

Measure
Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks
time frame: 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
time frame: 8 weeks

Secondary Outcomes

Measure
Urodynamic investigation
time frame: 4 and 8 weeks
Standardised Pad test
time frame: 4 and 8 weeks
Number of severe urinary stress incontinence episodes
time frame: 4 and 8 weeks
Number of sanitary napkins used
time frame: 4 and 8 weeks
Leakage index
time frame: 4 and 8 weeks
Subjective appreciation of patients
time frame: 4 and 8 weeks

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by Akontis.