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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®

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring radical prostatectomy , Device,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

Time Frame

12 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

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

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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