Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling

August 15, 2023 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients from the urology clinic.

Description

Inclusion Criteria:

  • The control group:
  • normal male subjects
  • The Intervention group:
  • male
  • with stress urinary incontinence
  • 45 years or older
  • history of prior radical prostatectomy
  • complains of stress urinary incontinence
  • scheduled for a transobturator sling surgery
  • ability and willingness to provide written consent

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre and Post Sling Pelvic MRI
Cohort: Measure change in hypermobility of urethra after transobturator sling surgery via pelvic MRI.
Other: Pre and Post Sling Pelvic MRI
Pre and Post Sling Pelvic MRI
Other Names:
  • Transobturator suspension sling system (TOS), AMS Advance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 2-5 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Andrew Peterson, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimated)

January 30, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00026977

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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