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Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy

NCT01832831 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2016-04-21

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Anne Pelletier-Cameron, MD · University of Michigan

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-02-28
Completion
2014-12-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01832831 on ClinicalTrials.gov