Trial Search Results

Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Cook MyoSite

Stanford Investigator(s):

Intervention(s):

  • Biological: Roll-in
  • Other: Placebo
  • Biological: AMDC for USR

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Female patient has primary symptoms of SUI, as confirmed by patient medical history
   and clinical symptoms, including a focused incontinence evaluation.

Exclusion Criteria:

   - Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of
   etiology from a patient medical history, including a focused incontinence history.

   - Patient has symptoms of mixed urinary incontinence where urge incontinence is the
   predominant factor.

   - Patient has had stress urinary incontinence symptoms less than 6 months prior to
   signing the informed consent.

   - Patient has not previously attempted conservative treatment prior to signing the
   informed consent. (Examples of conservative treatment include behavior modifications,
   bladder exercises, biofeedback, etc.)

   - Patient has more than 2 episode of awakening to void during normal sleeping hours.

   - Patient cannot be maintained on a stable dose and/or frequency of medication
   (including diuretics) known to affect lower urinary tract function, including but not
   limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers,
   for at least 2 weeks prior to screening or is likely to change during the course of
   the study.

   - Patient is pregnant, lactating, or plans to become pregnant during the course of the
   study.

   - Patient refuses to provide written informed consent.

   - Patient is not at least 18 years of age.

   - Patient is not available for the follow-up evaluations as required by the protocol.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Eric Sokol, MD
650-725-5986
Recruiting