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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01779323
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment
Male Stress Urinary Incontinence Other: Pre and Post Sling Pelvic MRI

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
Study Start Date : March 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

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 Name: Transobturator suspension sling system (TOS), AMS Advance

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients from the urology clinic.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01779323

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Andrew Peterson, MD Duke University

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Responsible Party: Duke University Identifier: NCT01779323     History of Changes
Other Study ID Numbers: Pro00026977
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: March 2016
Keywords provided by Duke University:
stress urinary incontinence
transobturator sling
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders