Trial Search Results

Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair

This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo in the treatment of stress urinary incontinence (SUI) in adult female patients. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Cook MyoSite

Stanford Investigator(s):

Intervention(s):

  • Biological: AMDC-USR
  • Other: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Adult female patient 50 to 75 years of age who has primary and moderate-to-severe
   symptoms of SUI for at least 6 months, as confirmed by patient medical history and
   clinical symptoms, including a focused incontinence evaluation.

   - Must be willing and able to comply with the study procedures, be mentally competent
   and able to understand all study requirements, and must agree to read and sign the
   informed consent form prior to any study-related procedures.

   - Must have completed 100% of the screening 3-day diary evening reports.

Exclusion Criteria:

   - Patient has symptoms of only 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, pelvic floor muscle therapy, etc.)

   - Patient BMI ≥ 35.

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

   - If taking a medication known to affect lower urinary tract function, including but not
   limited to, anticholinergics, beta 3 adrenergic receptor agonists, tricyclic
   antidepressants, serotonin-norepinephrine reuptake inhibitor (SNRI) or selective
   serotonin reuptake inhibitor (SSRI) antidepressants, diuretics, or alpha-adrenergic
   blockers, patient cannot be maintained on a stable dose and/or frequency of medication
   (including diuretics), cannot be maintained on a stable dose and/or frequency for at
   least 2 weeks prior to screening or is likely to change during the course of the
   study.

   - History of cancer in pelvic organs, ureters, or kidneys.

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

Ages Eligible for Study

50 Years - 75 Years

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Batham
650-724-7826
Recruiting