Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence (PROSPECT)
Primary Purpose
Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ustrap®
AMS 800®
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring radical prostatectomy , 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
Sites / Locations
- CHU Charles NicolleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ustrap®
AMS 800®
Arm Description
Ustrap is a new adjustable-pressure 4-arm device
Artificial sphincter currently considered the gold standard device in this field
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03323554
First Posted
October 24, 2017
Last Updated
September 15, 2020
Sponsor
Quanta Medical
Collaborators
Cousin Biotech
1. Study Identification
Unique Protocol Identification Number
NCT03323554
Brief Title
Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence
Acronym
PROSPECT
Official Title
Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. An Open, Randomised, Multicentre Study Versus Artificial Sphincter.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quanta Medical
Collaborators
Cousin Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
radical prostatectomy , Device,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
321 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ustrap®
Arm Type
Experimental
Arm Description
Ustrap is a new adjustable-pressure 4-arm device
Arm Title
AMS 800®
Arm Type
Active Comparator
Arm Description
Artificial sphincter currently considered the gold standard device in this field
Intervention Type
Device
Intervention Name(s)
Ustrap®
Intervention Description
Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach.
Intervention Type
Device
Intervention Name(s)
AMS 800®
Intervention Description
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 Measure Information:
Title
comparison of succes rate
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Nicolas Cornu, MD,Professor
Phone
02 32 88 33 41
Email
Jean-Nicolas.Cornu@chu-rouen.fr
Facility Information:
Facility Name
CHU Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Nicolas Cornu, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20025026
Citation
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.
Results Reference
background
Links:
URL
http://uroweb.org/guideline/urinary-incontinence
Description
Related Info
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Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence
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