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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01779323
First received: January 28, 2013
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Male Stress Urinary Incontinence.
Other: Pre and Post Sling Pelvic MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in urethral mobility [ Time Frame: Within 2-5 months after enrollment ] [ Designated as safety issue: No ]
    Measure change in urethral mobility from baseline versus 2-5 months post-surgery versus no surgical intervention.


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Pre and Post Sling Pelvic MRI
Other Name: Transobturator suspension sling system (TOS), AMS Advance

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients from the urology clinic.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779323

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Andrew Peterson, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01779323     History of Changes
Other Study ID Numbers: Pro00026977
Study First Received: January 28, 2013
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
SUI
stress urinary incontinence
male
transobturator sling

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014