Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

NCT03323554 | Active Not Recruiting DMC

• 1 other identifier: 2782
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence

Keywords

radical prostatectomy , Device,

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ustrap®

EXPERIMENTAL

Ustrap is a new adjustable-pressure 4-arm device

Device: Ustrap®

AMS 800®

ACTIVE COMPARATOR

Artificial sphincter currently considered the gold standard device in this field

Device: AMS 800®

Interventions

Ustrap® DEVICE

Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach.

Ustrap®

AMS 800® DEVICE

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).

AMS 800®

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease-related criteria:
• persistent urinary incontinence \>= 12 months following radical prostatectomy for prostate adenocarcinoma
• presenting an indication for surgical insertion of a medical device
• h 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Quanta Medical: lead
• Cousin Biotech: collaborator

Study Sites (1)

CHU Charles Nicolle

Rouen, 76031, France

Location

Related Publications (1)

• 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.

  PMID: 20025026 BACKGROUND

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a prospective, randomised, multicentre, comparative, open label, non-inferiority study in parallel groups of patients presenting stress urinary incontinence following prostate ablation for cancer.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: June 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)