Clinical trial NCT02490917: ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence
Official title: Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: Female urinary incontinence
Sphincter deficiency
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months.

Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day

Detailed description: Prospective multicenter randomized controlled trial comparing two parallel arms: the implantation of an adjustable balloon (experimental arm) versus implantation of an artificial urinary sphincter AMS800 ™ (control arm), for the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).

This research will focus on the assessment of improved continence, quality of life, and Cost-Effectiveness Analysis.

The tested device ACT ™ device is a prosthesis used to support the bladder neck and proximal urethra increasing the urethral coaptation and supporting to the bladder neck to prevent urine leakage at stress.

The medical device AMS 800 ™(control arm) is an implantable device made of silicone elastomer filled with saline/X-Ray fluid, used in the treatment of stress urinary incontinence related to ISD. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by closing the urethra and allowing the patient to void according to the patient's will and opening of the device (sub-cutaneous pump).

An inclusion visit will take place between 3 months and 1 month before the date of the surgery to explain the purpose of the study, the benefits and risks for patients, and describe the comparative medical devices.

Patients will be randomized before surgery (at D0).

The follow-up will be conducted up to one year, with scheduled visits at M1, M3, M6 and M12.

Secondary endpoints will be assessed during scheduled visits.

The medico-economic assessment will be made during the same follow-up period. This period will take into account improvement of urinary continence and results reported from the 3rd month as well as the morbidity and mortality related to the implementation of the medical device up to 1 year.

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Eligibility criteria: Inclusion Criteria:

* Patients suffering from stress urinary incontinence due to ISD.
* Patients with maximum urethral closure pressure(PCUM) \< 50 cm H2O or bladder leakage pressure \< 100 cm H2O
* Patient who accepted surgery
* Patient with normal urethra-cystoscopy (no foreign body nor calculus)
* Patient with effort leaks on clinical examination
* Patient who never had SUA or ACT ™ balloon
* Affiliation to health insurance
* Written informed consent

Exclusion Criteria:

* Patient pregnant or breastfeeding
* Patient with a life expectancy of less than 2 years
* Patient with overactive bladder uncontrolled and considered an against-indication for surgery
* Patient with reduced bladder compliance
* Patient with significant post-void residual volume according to the judgment of the Investigator
* Patient with a history of pelvic radiotherapy

Primary outcomes:
measure: Social continence defined by the use of 0-1 adult protective pads per day
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of incontinence (number and type of protective pads used per day)
timeFrame: 12 months
measure: impact on quality of life assessed by EQ-5D Health Questionnaire.
timeFrame: 12 months
measure: assessment of the urinary flow using ICIQ-FLUTS questionnaire
timeFrame: 12 months
measure: Assessment of Urinary Profile Symptoms using UPS questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Urology Department, Pitié-Salpêtrière University Hospital
Study officials:
affiliation: Urology Department, Pitié-Salpêtrière University Hospital, 75013 Paris, France
name: CHARTIER-KASTLER EMMANUEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: