Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cook MyoSite
This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male, at least 18 years old, with primary symptoms of SUI following prostate surgery,
Patient has undergone prostate surgery but has not undergone radiation therapy, cryotherapy, or high-intensity focused ultrasound of the prostate,
SUI severity should be ≥10 g and \<400 g of urine leakage over 24 hours,
Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.
You may not be if
Symptoms of only urge urinary incontinence,
Symptoms of stress urinary incontinence prior to prostate surgery,
Routinely has more than 2 episodes of awakening to void during normal sleeping hours,
Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy,
Previously treated with a periurethral balloon or adjustable sling for urinary incontinence,
Symptoms of overflow incontinence
Additional medical restrictions as specified in the Clinical Investigation Plan,
Additional anatomical restrictions as specified in the Clinical Investigation Plan.
