Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 is a clinical trial that was terminated before completion, run by University of Michigan. The registered enrollment target is 24 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2010-05
Est. Completion 2014-12

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT01832831

The ClinicalTrials.gov registry entry for NCT01832831 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01832831 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.