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NCT01832831 · ClinicalTrials.gov registry record
Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy
A clinical trial, sponsored by University of Michigan.
- Terminated
- Registry status
- 24
- Enrollment target
NCT01832831: Clinical Trial study, sponsored by University of Michigan.
NCT01832831 is a clinical trial that was terminated before completion, run by University of Michigan. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01832831 was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- 24 participants
- Enrollment target
Study Summary
One out of every six men will be diagnosed with prostate cancer and post prostatectomy up to 75% report urinary incontinence. There are many hypotheses about the exact cause of post prostatectomy stress incontinence (PPI). Existing studies have focused on surgical or cadaveric dissections to define structures responsible for PPI. Contemporary 3T MRI now allows three dimensional, sub-millimeter resolution of the human pelvis and clearly demonstrates pelvic anatomy without the distortion of dissection. It is our overarching hypothesis that PPI is multifactorial and occurs because of a combination of specific anatomical and functional impairments. We propose conducting a case control study with matching for age and race to compare the MRI anatomy and urinary tract function on urodynamics between 20 men with PPI (cases) and 20 men who are continent post prostatectomy (controls) who are all a minimum of 12 months post surgery. We will use static and dynamic MRI at 3 Tesla to make objective measurements of the bladder neck, external urethral sphincter, pelvic floor, urethral anastomotic fibrosis, and urethral hypermobility- all believed to play a large part in continence. Multi-channel urodynamic studies will also be performed to assess the leak point and maximum urethral closure pressure. All cases and controls will complete standardized questionnaires - the AUA symptom index and the Incontinence Severity Index as a quality of life measure. This study is needed to provide critical information about causes of male PPI, a quality of life altering voiding dysfunction, and will assist with the advancement of pharmacological and surgical treatment of this disease.
Primary Outcome
Structural assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-12 |
Why NCT01832831 stopped before completion
NCT01832831 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01832831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01832831 about?
NCT01832831 is a clinical study titled "Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy". One out of every six men will be diagnosed with prostate cancer and post prostatectomy up to 75% report urinary incontinence. There are many hypotheses about the exact cause of post prostatectomy stress incontinence (PPI). Existing studies have focused on surgical or cadaveric dissections to define ...
What is the current status of trial NCT01832831?
This trial is currently terminated. The enrollment target is 24 participants. The study started on 2010-05. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT01832831?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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