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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01779323

Enrollment

Registered

2013-01-30

Start date

2012-03-31

Completion date

2014-09-30

Last updated

2023-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Stress Urinary Incontinence

Keywords

SUI, stress urinary incontinence, male, transobturator sling

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.

Interventions

OTHERPre and Post Sling Pelvic MRI

Pre and Post Sling Pelvic MRI

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in urethral mobility	Within 2-5 months after enrollment	Measure change in urethral mobility from baseline versus 2-5 months post-surgery versus no surgical intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026