Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence (PROSPECT)

Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. an Open, Randomised, Multicentre Study Versus Artificial Sphincter.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Ustrap®; Device: AMS 800®

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • CHU Charles Nicolle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Disease-related criteria:

• persistent urinary incontinence >= 12 months following radical prostatectomy for prostate adenocarcinoma
• presenting an indication for surgical insertion of a medical device
• 24h PAD test > 100 g per day
• controlled prostate adenocarcinoma, with PSA ≤ 1 ng/ml

Population-related criteria:

• male subjects aged 18 years and over
• having provided free, informed written consent to take part in the study
• patients independent and able to use the collar without difficulty and able to manage an artificial sphincter
• Patient able to understand and sign the consent form and to complete questionnaires
• Patient without mental impairment
• Patients belonging to or covered by Social Security.

Exclusion Criteria:

Disease-related criteria:

• Documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms.
• Presence of urethral anastomotic stenosis preventing passage of the fiberscope at the initial endoscopy
• Severe symptomatic hyperactive or hypoactive bladder not controlled by drug therapy
• Severe constitutional haemorrhagic disease or haemophilia
• Patients presenting urinary infection not controlled
• Patients presenting severe renal failure and obstructive pathologies of the upper urinary tract with severe renal failure.
• Patients presenting deep immune deficiency
• Patient presenting recto-urethral fistula
• Patient with tumor of bladder
• Patient having bladder stones with failure of bladder stone treatment

Criteria related to incontinence treatment:

• Allergy to any of the components of the medical devices
• History of surgery to insert a medical device for treatment of incontinence (e.g. artificial sphincter, suburethral strap, continence balloons, etc.)
• History of periurethral injection of filling agents
• Inability to use either of the study devices
• Drug treatment: duloxetine or any treatment likely to modify continence results
• Not receiving and not likely to receive radiotherapy at any time throughout the 12-month follow-up period Population-related criteria
• Foreseeable unavailability during the study . Patient deprived of liberty by administrative or judicial decision or under legal guardianship
• Participation in another clinical trial in the 3 months preceding the initial visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ustrap®; Ustrap is a new adjustable-pressure 4-arm device	Device: Ustrap®; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of succes rate	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.	12 months

Collaborators and Investigators

• Sponsor: Quanta Medical
• Collaborators: Cousin Biotech

Publications and helpful links

General Publications

• Herschorn S, Bruschini H, Comiter C, Grise P, Hanus T, Kirschner-Hermanns R, Abrams P; Committee of the International Consultation on Incontinence. Surgical treatment of stress incontinence in men. Neurourol Urodyn. 2010;29(1):179-90. doi: 10.1002/nau.20844.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: radical prostatectomy , Device,
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 2782 (Sir Halley Stewart Trust)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No