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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT05860634
Eligibility Criteria:
Inclusion Criteria:
1. Are at least 18 years of age
2. Are fluent and able to read in English or Spanish
3. Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinous ligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy, and/or mid-urethral sling) that occurs on Monday - Thursday
4. Have transurethral catheter in place at the conclusion of surgery as part of standard care
5. Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
6. Are discharged home on the same day of surgery (POD 0)
Exclusion Criteria:
1. Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
2. Have physical or mental impairment that would impact their ability to remove their catheter themselves.
3. Undergo urethral bulking injections as part of surgery
4. Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05860634
Study Brief:
Protocol Section:
NCT05860634