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

Akontis

Status and phase: Unknown; Phase 2

Conditions: Urinary Stress Incontinence

Treatments: Device: transvaginal placebo device; Device: transvaginal electrical stimulation device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762593

KEAT F1

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

transvaginal electrical stimulation with a home use programmable device used 30 minutes every day during 8 weeks

Treatment:

Device: transvaginal electrical stimulation device

2

Placebo Comparator group

Description:

Use of a transvaginal placebo home use programmable device used 30 minutes every day during 8 weeks

Treatment:

Device: transvaginal placebo device