Male Stress Urinary IncontinenceNCT01779323
Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
An observational study of Male Stress Urinary Incontinence, run by Duke University at 1 site in United States.
Trial summary
The hypothesis is men with stress urinary incontinence, including those following radical retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as measured by magnetic resonance imaging (MRI) that improves significantly following sling placement. Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Stress Urinary Incontinence
- What is being tested?
- Pre and Post Sling Pelvic MRI
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from the urology clinic.
Who may be able to join
- The control group:
- normal male subjects
- The Intervention group:
- male
- with stress urinary incontinence
- 45 years or older
Show all 10Show fewer
- history of prior radical prostatectomy
- complains of stress urinary incontinence
- scheduled for a transobturator sling surgery
- ability and willingness to provide written consent
Who cannot join
- absolute or relative contraindications to MRI
- claustrophobia
- inability to undergo the male sling surgery
- PI judgement
- Absolute contraindications to MRI:
- electronically, magnetically, and mechanically activated implants
Show all 17Show fewer
- ferromagnetic or electronically operated active devices
- metallic splinters in the eye
- ferromagnetic hemostatic clips in the central nervous system
- Relative contraindications to MRI:
- cochlear implants
- other pacemakers
- nerve stimulators
- lead wires or similar wires
- prosthetic heart valves
- hemostatic clips
- non-ferromagnetic stapedial implants
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Prospective Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
The hypothesis is men with stress urinary incontinence, including those following radical retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as measured by magnetic resonance imaging (MRI) that improves significantly following sling placement. The investigators theorize that the sling helps with primary hypermobility of this pathophysiologic cause of stress urinary incontinence.
- Conditions
- Male Stress Urinary Incontinence
- Being tested
- Pre and Post Sling Pelvic MRI
- Keywords
- SUI, stress urinary incontinence, male, transobturator sling
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre and Post Sling Pelvic MRIOther
Also called Transobturator suspension sling system (TOS), AMS Advance
Pre and Post Sling Pelvic MRI
| Study group | Role | What they receive |
|---|---|---|
| Pre and Post Sling Pelvic MRI | Cohort: Measure change in hypermobility of urethra after transobturator sling surgery via pelvic MRI. Receives: Other: Pre and Post Sling Pelvic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urethral mobility
Measure change in urethral mobility from baseline versus 2-5 months post-surgery versus no surgical intervention.
Measured: Within 2-5 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Peterson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779323
- Sponsor's protocol ID
- Pro00026977
- Status last verified
- Mar 2016
- First submitted
- 28 Jan 2013
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
- ClinicalTrials.gov ID
- NCT01779323
- Acronym / sponsor ID
- Pro00026977
- Conditions
- Male Stress Urinary Incontinence
- Keywords
- SUI, stress urinary incontinence, male, transobturator sling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Jan 2013 (estimated)
- 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.
The hypothesis is men with stress urinary incontinence, including those following radical retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as measured by magnetic resonance imaging (MRI) that improves significantly following sling placement. The investigators theorize that the sling helps with primary hypermobility of this pathophysiologic cause of stress urinary incontinence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre and Post Sling Pelvic MRI | – | Other: Pre and Post Sling Pelvic MRICohort: Measure change in hypermobility of urethra after transobturator sling surgery via pelvic MRI. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the urology clinic.
Key inclusion criteria (10 listed)
- The control group:
- normal male subjects
- The Intervention group:
- male
- with stress urinary incontinence
Key exclusion criteria (17 listed)
- absolute or relative contraindications to MRI
- claustrophobia
- inability to undergo the male sling surgery
- PI judgement
- electronically, magnetically, and mechanically activated implants
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 |
|---|---|---|
| Pre and Post Sling Pelvic MRIAlso: Transobturator suspension sling system (TOS), AMS AdvancePre and Post Sling Pelvic MRI | Other | Pre and Post Sling Pelvic MRI |
Primary outcome
Change in urethral mobility
Time frame: Within 2-5 months after enrollment
Measure change in urethral mobility from baseline versus 2-5 months post-surgery versus no surgical intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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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.
Andrew Peterson, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Stress Urinary Incontinence, run by Duke University at 1 site in United States.
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 10 inclusion and 17 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: finished, as of the sponsor's last update on 16 Aug 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in urethral mobility (time frame: Within 2-5 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2023.