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

Duke University

Status: Completed

Conditions: Male Stress Urinary Incontinence

Treatments: Other: Pre and Post Sling Pelvic MRI

Study type: Observational

Funder types: Other

Identifiers

NCT01779323

Pro00026977

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Male

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

34 participants in 1 patient group

Pre and Post Sling Pelvic MRI

Description:

Cohort: Measure change in hypermobility of urethra after transobturator sling surgery via pelvic MRI.

Treatment:

Other: Pre and Post Sling Pelvic MRI