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

Completed

• Conditions: Male Stress Urinary Incontinence
• Interventions: Other: Pre and Post Sling Pelvic MRI

• Registration Number: NCT01779323
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-30
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-03
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre and Post Sling Pelvic MRI	Pre and Post Sling Pelvic MRI	Cohort: Measure change in hypermobility of urethra after transobturator sling surgery via pelvic MRI.

Primary Outcome Measures

Name	Time	Method
Change in urethral mobility	Within 2-5 months after enrollment	Measure change in urethral mobility from baseline versus 2-5 months post-surgery versus no surgical intervention.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States