Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

NCT ID: NCT03323554

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2026-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ustrap®

Ustrap is a new adjustable-pressure 4-arm device

Group Type: EXPERIMENTAL

Ustrap®

Intervention Type: DEVICE

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

AMS 800®

Artificial sphincter currently considered the gold standard device in this field

Group Type: ACTIVE_COMPARATOR

AMS 800®

Intervention Type: 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).

Interventions

Ustrap®

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

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cousin Biotech

INDUSTRY

Sponsor Role: collaborator

Quanta Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Charles Nicolle

Rouen, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 20025026 (View on PubMed)

Related Links

http://uroweb.org/guideline/urinary-incontinence

Related Info

https://doi.org/10.1016/S1569-9056(16)60199-9

Related Info

Other Identifiers

2782

Identifier Type: -

Identifier Source: org_study_id