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

February 20, 2025 updated by: TriHealth Inc.

Peri-operative Tamsulosin and Impact on Voiding Trial Following Outpatient Urogynecology Surgery: a Randomized Controlled Trial

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth
        • Contact:
        • Principal Investigator:
          • Catrina Crisp, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Arm
Drug: Placebo
This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.
Active Comparator: Study Arm
Drug: 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.
Other Names:
  • Flomax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voiding trial on postoperative day 0
Time Frame: Day of surgery
Whether or not patients pass or fail their postoperative voiding trial
Day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary postoperative urinary retention
Time Frame: 2 weeks following surgery
Patients who develop urinary retention after discharge
2 weeks following surgery
Postoperative urinary tract infection
Time Frame: 30 days after surgery
Patients who develop a urinary tract infection after surgery
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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