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

NCT01779323 | Completed

• 1 other identifier: Pro00026977
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Stress Urinary Incontinence

Keywords

SUI; stress urinary incontinence; male; transobturator sling

Outcome Measures

Primary Outcomes (1)

• Change in urethral mobility

  Measure change in urethral mobility from baseline versus 2-5 months post-surgery versus no surgical intervention.

  Within 2-5 months after enrollment

Study Arms (1)

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

Interventions

Pre and Post Sling Pelvic MRI OTHER

Pre and Post Sling Pelvic MRI

Also known as: Transobturator suspension sling system (TOS), AMS Advance

Pre and Post Sling Pelvic MRI

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the urology clinic.

You may qualify if:

• The control group:
• normal male subjects
• The Intervention group:
• male
• with stress urinary incontinence
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Lead

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Andrew Peterson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 16, 2023

Record last verified: 2016-03

Locations

US (1)