Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair for Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment

Inclusion Criteria:

   - Adult female patient ≥ 18 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.

   - History of previous surgery for treatment of SUI. Previous surgery could include
   midurethral sling, retropubic suspension, or bladder neck sling. Bulking agents alone
   are not considered previous surgery for treatment of SUI.

   - 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.