Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery

NCT06843538 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 24-108
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Voiding trial on postoperative day 0

  Whether or not patients pass or fail their postoperative voiding trial

  Day of surgery

Secondary Outcomes (2)

• Secondary postoperative urinary retention

  2 weeks following surgery

• Postoperative urinary tract infection

  30 days after surgery

Study Arms (2)

Study Arm

ACTIVE COMPARATOR

Drug: Tamsulosin

Control Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tamsulosin DRUG

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.

Also known as: Flomax

Study Arm

Placebo DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients undergoing any pelvic organ prolapse repair or incontinence surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth

Cincinnati, Ohio, 45220, United States

RECRUITING

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Central Study Contacts

Gisele C Moran, MD, MPH

CONTACT

513-862-1123; gisele_moran@trihealth.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: February 3, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)