Urinary IncontinencePROSPECTNCT03323554
Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence
A study testing Ustrap® and AMS 800® in people with Urinary Incontinence, run by Quanta Medical at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Ustrap® and AMS 800®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. an Open, Randomised, Multicentre Study Versus Artificial Sphincter.
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.
- Conditions
- Urinary Incontinence
- Being tested
- Ustrap®, AMS 800®
- Keywords
- radical prostatectomy , Device,
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ustrap®Device
Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach.
AMS 800®Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Ustrap® | Experimental | Ustrap is a new adjustable-pressure 4-arm device Receives: Device: Ustrap® |
| AMS 800® | Active comparator | Artificial sphincter currently considered the gold standard device in this field Receives: Device: AMS 800® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Jun 2018
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323554
- Sponsor's protocol ID
- 2782
- Acronym
- PROSPECT
- Status last verified
- Jul 2024
- First submitted
- 24 Oct 2017
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20025026
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Interventional Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence. an Open, Randomised, Multicentre Study Versus Artificial Sphincter.
- ClinicalTrials.gov ID
- NCT03323554
- Acronym / sponsor ID
- PROSPECT / 2782
- Conditions
- Urinary Incontinence
- Keywords
- radical prostatectomy , Device,
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Quanta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ustrap® | Experimental | Device: Ustrap®Ustrap is a new adjustable-pressure 4-arm device |
| AMS 800® | Active comparator | Device: AMS 800®Artificial sphincter currently considered the gold standard device in this field |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- male subjects aged 18 years and over
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ustrap®Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach. | Device | Ustrap® |
| 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). | Device | AMS 800® |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 20025026Herschorn 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ustrap® and AMS 800® in people with Urinary Incontinence, run by Quanta Medical at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of succes rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.