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

Male Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779323
• Other study ID #: Pro00026977
• Status: Completed
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Male Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Pre and Post Sling Pelvic MRI
Pre and Post Sling Pelvic MRI

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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