ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence (SU-ACT)

November 17, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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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Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Urology Department, Pitié-Salpêtrière University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT™ device
Patients randomized to receive the Adjustable Continence Therapy device ACT™
Device: ACT™ device
Implantation of the Adjustable Continence Therapy device ACT®
Other: AMS 800 ™ device
Patients randomized to receive the artificial urinary sphincter AMS 800 ™
Device: AMS 800 ™ device
Implantation of the artificial urinary sphincter AMS 800 ™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Social continence defined by the use of 0-1 adult protective pads per day
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of incontinence (number and type of protective pads used per day)
Time Frame: 12 months
12 months
impact on quality of life assessed by EQ-5D Health Questionnaire.
Time Frame: 12 months
12 months
assessment of the urinary flow using ICIQ-FLUTS questionnaire
Time Frame: 12 months
12 months
Assessment of Urinary Profile Symptoms using UPS questionnaire
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: CHARTIER-KASTLER EMMANUEL, MD, PhD, Urology Department, Pitié-Salpêtrière University Hospital, 75013 Paris, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P130941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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