An observational study in Prostate Cancer and Post Prostatectomy Incontinence, sponsored by University of Michigan. Terminated at 2 sites in United States. Open to male participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-21.
Sponsored by University of Michigan · Observational
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.
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This study's enrollment of 24 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
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primary care clinic
Exclusion Criteria:
Thickness and length of both the smooth muscle and striated muscle external urethral sphincter
Structural assessment
Time frame: 2 years
Posterior urethral length from the bladder neck to the perineal membrane.
Structural assessment
Time frame: 2 years
Levator ani thickness
Structural assessment
Time frame: 3 years
Thickness and length of anastomotic fibrosis in both sagittal and axial planes
Structural assessment
Time frame: 3 years
Maximal urethral closure pressure
Functional assessment
Time frame: 3 years
Increase in urethral pressure during maximal muscle contraction
Functional assessment
Time frame: 3 years
Urethral hypermobility on MRI
Functional assessment
Time frame: 3 years
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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University of Michigan