Recruiting
Phase 3

Tamsulosin

Sponsor:

TriHealth Inc.

Code:

NCT06843538

Conditions

Postoperative Urinary Retention (POUR)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tamsulosin

Placebo

Study Details

Brief summary:

The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).

Conditions

Postoperative Urinary Retention (POUR)

Study ID

NCT06843538

Start date

Feb 3, 2025

Status verified date

Feb, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Feb 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

- Patients undergoing any pelvic organ prolapse repair or incontinence surgery

Exclusion Criteria:

  • Any surgery involving a non-urogynecologist
  • Patients already on an alpha blocker
  • Baseline hypotension
  • History of syncope
  • Postural orthostatic tachycardia syndrome (POTS)
  • Non-English speaker or interpreter unavailable for Spanish-speaking patient
  • Impaired cognition impeding proper consenting
  • Any other medical contraindication for tamsulosin use
  • History of urinary retention requiring continuous or intermittent catheterization
  • Patients consented for the study but then due to intraoperative complication, routine voiding trial no longer indicated due to requiring indwelling catheter or intermittent catheterization on discharge will be excluded from primary outcome analysis
  • Pregnancy

Study Design

Enrollment

166 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Study Arm

placebo comparator: Control Arm

Interventions

Tamsulosin

This intervention will investigate if tamsulosin will decrease postoperative urinary retention. Subjects will be directed to start taking the medication 5-7 days prior to their procedure; as previous studies have shown, this is when tamsulosin reaches its steady state. Patients will continue to take their assigned pills for 7 days postoperatively.

Placebo

This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.

Primary outcome measure

  • Voiding trial on postoperative day 0 [ Time Frame: Day of surgery ]

Central Contacts and Locations

Central contacts

Gisele C Moran, MD, MPH

513-862-1123gisele_moran@trihealth.com

Locations

TriHealth

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Jenny Hodge, RN

513-862-2056Jennifer_Hodge2@trihealth.com

Principal Investigator:

Catrina Crisp, MD, MSc

More Information

Sponsor

TriHealth Inc.

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TriHealth Inc. on 2025-02-25.