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

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ClinicalTrials.gov Identifier: NCT02490917
Recruitment Status : Recruiting
First Posted : July 7, 2015
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: ACT™ device Device: AMS 800 ™ device Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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™)
Actual Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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®

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 ™




Primary Outcome Measures :
  1. Social continence defined by the use of 0-1 adult protective pads per day [ Time Frame: 6 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490917


Contacts
Contact: CHARTIER-KASTLER EMMANUEL, MD, PhD +33(0)142177129 emmanuel.chartier-kastler@aphp.fr

Locations
France
Urology Department, Pitié-Salpêtrière University Hospital Recruiting
Paris, France, 75013
Contact: CHARTIER-KASTLER EMMANUEL, MD, PhD    +33(0)142177129    emmanuel.chartier-kastler@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: CHARTIER-KASTLER EMMANUEL, MD, PhD Urology Department, Pitié-Salpêtrière University Hospital, 75013 Paris, France

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02490917     History of Changes
Other Study ID Numbers: P130941
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Female urinary incontinence
Sphincter deficiency

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders