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:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT05408533
Eligibility Criteria:
Inclusion Criteria:
* Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.
Exclusion Criteria:
* Unwilling or unable to participate in the study.
* Unwilling or unable to do a catheter self-removal at home.
* Inability to understand English.
* Pregnant women
* Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids.
* Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
* Active urinary tract infection.
* Intraoperative bladder injury or cystotomy
* Physical or mental impairment that would affect the subject's ability to perceive urinary tract infection symptoms
* Reported allergy to silver metal
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05408533
Study Brief:
Protocol Section:
NCT05408533