Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

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.