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Trial record 22 of 159 for:    Recruiting, Not yet recruiting, Available Studies | "Enuresis"

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

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ClinicalTrials.gov Identifier: NCT03323554
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
Cousin Biotech
Information provided by (Responsible Party):
Quanta Medical

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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: Ustrap® Device: AMS 800® Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a prospective, randomised, multicentre, comparative, open label, non-inferiority study in parallel groups of patients presenting stress urinary incontinence following prostate ablation for cancer.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. An Open, Randomised, Multicentre Study Versus Artificial Sphincter.
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. comparison of succes rate [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323554


Contacts
Contact: Jean Nicolas Cornu, MD,Professor 02 32 88 33 41 Jean-Nicolas.Cornu@chu-rouen.fr

Locations
France
CHU Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Jean-Nicolas Cornu, MD, PhD         
Sponsors and Collaborators
Quanta Medical
Cousin Biotech

Additional Information:
Publications:
Responsible Party: Quanta Medical
ClinicalTrials.gov Identifier: NCT03323554     History of Changes
Other Study ID Numbers: 2782
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Quanta Medical:
radical prostatectomy , Device,

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders