Urinary Incontinence Research

For enrollment information involving the following trial, please contact a member of our research support staff.

Female MyoSite Study

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence (SUI); 1 ≤ daily stress leaks per diary ≤ 15

Inclusion Criteria:

  • Adult female with primary and moderate-to-severe symptoms of SUI

  • Must be able to void spontaneously

  • Low hypermobility of urethra with Valsalva Q-tip, ≤30°

  • Bladder capacity of ≥200 mL

Exclusion Criteria

  • An average greater than 15 stress incontinent episodes per day

  • Symptoms of only urge incontinence

  • Symptoms of SUI for les than six months prior to signing consent  

  • Routinely has more than two episodes of awakening to void during normal sleeping hours

  • Indwelling catheter or require intermittent catheterization

  • Neuromuscular disorder

  • Morbidly obese (BMI>35)

  • History of cancer in pelvic organs in past 12 months

  • History of radiation treatment to the urethra or adjacent structures

Sponsor: Cook MyoSite, Incorporated

Principal Investigator: Niall Galloway, MD

Co-Investigators & Collaborators: Gina Northington, MD, PhD (Department of Gynecology and Obstetrics)