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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02348112
Eligibility Criteria:
Inclusion Criteria:
* The subject is female and at least 18 years of age.
* The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
* The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics.
* The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for \> 6 months.
Exclusion Criteria:
* The subject has an active urogenital infection or active skin infection in region of surgery.
* The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.
* The subject is having a concomitant pelvic floor procedure.
* The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
* The subject had a prior surgical stress urinary incontinence (SUI) treatment.
* The subject has undergone radiation or brachy therapy to treat pelvic cancer.
* The subject has urge predominant incontinence by MESA assessment.
* The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.
* The subject is pregnant and/or is planning to get pregnant in the future.
* The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU).
* The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02348112
Study Brief:
Protocol Section:
NCT02348112