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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2027
  • participants needed
    321
  • sponsor
    Quanta Medical
Updated on 5 March 2022
prostatectomy
cancer
stress incontinence

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.

Details
Condition Urinary Incontinence
Treatment Ustrap®, AMS 800®
Clinical Study IdentifierNCT03323554
SponsorQuanta Medical
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

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
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

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
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