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

Urinary Stress Incontinence Clinical Trial

— KEAT F1  

Official title:

A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00762593
• Other study ID #: KEAT F1
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 29, 2008
• Last updated: October 16, 2008
• Start date: January 2006
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Akontis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Device:
• transvaginal placebo device
Use of a transvaginal placebo 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

Locations

Country	Name	City	State
France	Centre européen d'explorations gynécologiques	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Akontis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks		8 weeks	Yes
Primary	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	Yes
Secondary	Urodynamic investigation		4 and 8 weeks	No
Secondary	Standardised Pad test		4 and 8 weeks	No
Secondary	Number of severe urinary stress incontinence episodes		4 and 8 weeks	No
Secondary	Number of sanitary napkins used		4 and 8 weeks	No
Secondary	Leakage index		4 and 8 weeks	No
Secondary	Subjective appreciation of patients		4 and 8 weeks	No