Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence (KEAT F1)

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

To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women

Study Overview

• Status: Unknown
• Conditions: Urinary Stress Incontinence
• Intervention / Treatment: Device: transvaginal electrical stimulation device; Device: transvaginal placebo device

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Centre européen d'explorations gynécologiques

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks	Device: transvaginal electrical stimulation device; Use of a transvaginal electrical stimulation home use programmable device used 30 minutes every day during 8 weeks
Placebo Comparator: 2; Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks	Device: transvaginal placebo device; Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Akontis

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Anticipated): October 1, 2008
• Study Completion (Anticipated): October 1, 2008

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): October 17, 2008
• Last Update Submitted That Met QC Criteria: October 16, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: urinary stress incontinence; urinary stress incontinence in women
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: KEAT F1