Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

Urinary Incontinence Clinical Trial

— PROSPECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03323554
• Other study ID #: 2782
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 1, 2027

Study information

• Verified date: September 2020
• Source: Quanta Medical
• Contact: Jean Nicolas Cornu, MD,Professor
• Phone: 02 32 88 33 41
• Email: Jean-Nicolas.Cornu[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 321
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
France	CHU Charles Nicolle	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Quanta Medical	Cousin Biotech

Country where clinical trial is conducted

France, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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