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

NCT ID: NCT01779323

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-09-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre and Post Sling Pelvic MRI

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

Pre and Post Sling Pelvic MRI

Intervention Type: OTHER

Pre and Post Sling Pelvic MRI

Interventions

Pre and Post Sling Pelvic MRI

Pre and Post Sling Pelvic MRI

Intervention Type: OTHER

Other Intervention Names

Transobturator suspension sling system (TOS), AMS Advance

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Peterson, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00026977

Identifier Type: -

Identifier Source: org_study_id