Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence (PROSPECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03323554|
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : July 13, 2018
Few surgical methods to treat male stress urinary incontinence have been assessed in comparative, randomised interventional studies.
Ustrap is a new adjustable-pressure 4-arm device. The artificial sphincter is currently considered the gold standard device in this field.
The aim of this randomised prospective international study is to assess the efficacy and safety of the Ustrap® device comparatively with an artificial sphincter (AMS800) in the treatment of stress urinary incontinence following prostate removal in cancer patients.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Device: Ustrap® Device: AMS 800®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||321 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||a prospective, randomised, multicentre, comparative, open label, non-inferiority study in parallel groups of patients presenting stress urinary incontinence following prostate ablation for cancer.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. An Open, Randomised, Multicentre Study Versus Artificial Sphincter.|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2024|
Ustrap is a new adjustable-pressure 4-arm device
Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach.
Active Comparator: AMS 800®
Artificial sphincter currently considered the gold standard device in this field
Device: AMS 800®
Patients will receive AMS 800® under general or loco-regional anaesthesia. Small openings are made near the scrotum and below the abdomen to insert an inflatable cuff, a pump and a small balloon (pressure regulating balloon).
- comparison of succes rate [ Time Frame: 12 months ]Succes being defined as the absence of use of protective pads, or in the case of use of safety protection comprising a test PAD over 24h, wet weight indicating collection of ≤ 10 g liquid, and the absence of corrective surgery.
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): NCT03323554
|Contact: Jean Nicolas Cornu, MD,Professor||02 32 88 33 41||Jean-Nicolas.Cornu@chu-rouen.fr|
|CHU Charles Nicolle||Recruiting|
|Rouen, France, 76031|
|Contact: Jean-Nicolas Cornu, MD, PhD|