Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT02291432
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02291432
Study Brief:
Protocol Section:
NCT02291432