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.

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Key information

Conditions

Male Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre and Post Sling Pelvic MRI

Other

Pre and Post Sling Pelvic MRI

Other names: Transobturator suspension sling system (TOS), AMS Advance

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jan 30, 2013
Registry last updated: Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed