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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT04682366
Eligibility Criteria:
Inclusion Criteria:
* Stage II or greater pelvic organ prolapse in \> 1 vaginal compartment
* Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health
* Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge
* Willing to remain compliant with Investigation Product (IP)
Exclusion Criteria:
* Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)
* Patients whose surgical plan would necessitate a voiding trial on postop day \>0
* Less than 21 years of age
* Unable to understand English
* Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty
* Patient with known allergy to Tamsulosin or sulfa drugs
* Patients with upcoming cataract surgery
* Patient with orthostatic hypotension
* History of postvoid residual (PVR\>150) prior to surgery with prolapse reduction
* Patients with hypertension on alpha-blockers
* Single compartment prolapse repair (anterior or posterior repair only)
* Use of mesh for prolapse repair
* High tone pelvic floor dysfunction
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT04682366
Study Brief:
Protocol Section:
NCT04682366