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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00762593
• Date of registration: 29/09/2008
• Prospective Registration: No
• Primary sponsor: Akontis
• Public title: Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence KEAT F1
• Scientific title: A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
• Date of first enrolment: January 2006
• Target sample size: 150
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00762593
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Urinary Stress Incontinence

Intervention(s)

Device: transvaginal electrical stimulation device

Device: transvaginal placebo device

Primary Outcome(s)

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 Outcome(s)

Leakage index [Time Frame: 4 and 8 weeks]

Urodynamic investigation [Time Frame: 4 and 8 weeks]

Number of sanitary napkins used [Time Frame: 4 and 8 weeks]

Subjective appreciation of patients [Time Frame: 4 and 8 weeks]

Number of severe urinary stress incontinence episodes [Time Frame: 4 and 8 weeks]

Standardised Pad test [Time Frame: 4 and 8 weeks]

Secondary ID(s)

KEAT F1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors