ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence
NCT ID: NCT02490917
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2015-09-30
2019-12-31
Brief Summary
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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
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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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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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ACT™ device
Patients randomized to receive the Adjustable Continence Therapy device ACT™
ACT™ device
Implantation of the Adjustable Continence Therapy device ACT®
AMS 800 ™ device
Patients randomized to receive the artificial urinary sphincter AMS 800 ™
AMS 800 ™ device
Implantation of the artificial urinary sphincter AMS 800 ™
Interventions
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ACT™ device
Implantation of the Adjustable Continence Therapy device ACT®
AMS 800 ™ device
Implantation of the artificial urinary sphincter AMS 800 ™
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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CHARTIER-KASTLER EMMANUEL, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Urology Department, Pitié-Salpêtrière University Hospital, 75013 Paris, France
Locations
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Urology Department, Pitié-Salpêtrière University Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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CHARTIER-KASTLER EMMANUEL, MD, PhD
Role: primary
Other Identifiers
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P130941
Identifier Type: -
Identifier Source: org_study_id