MedTrace Logo

Effect of Preoperative Tamsulosin on Postoperative Urinary Retention

NCT05753670 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2025-10-28

Study results available
· View outcomes & findings →

Summary

Approximately 25-30% of patients experience postoperative urinary retention after female pelvic surgery with mid-urethral sling placement. These patients are discharged home with a foley catheter for a few days. Despite being common, many patients consider being discharged home with a foley catheter as a complication of surgery and as the worst part of their experience. Previous studies have demonstrated that 3-5 days of preoperative tamsulosin (a safe and low-cost medication) have been shown to improve postoperative urinary retention rates. Although it takes tamsulosin 5 days to reach a steady-state in a patient, it reaches peak blood volume in 4-5 hours in a fasting patient. The effect of a single dose of preoperative tamsulosin on postoperative urinary retention has not been studied, however would be substantially easier for patients than multiple days of preoperative doses. In this study, the investigators would like to give patients preoperative tamsulosin versus placebo. The investigators would then evaluate for postoperative urinary retention. Previous studies have demonstrated a postoperative urinary retention rate decrease of 65-88% after various tamsulosin protocols. However, the effect of single preoperative dose of tamusloin on postoperative urinary retention has yet to be studied in female pelvic surgery. The investigators hypothesize that a single preoperative dose of tamsulosin will decrease the number of patients with postoperative urinary retention and therefore discharged with a foley catheter. Our goal is to improve patient outcomes and satisfaction postoperatively.

Conditions

  • Postoperative Retention of Urine

Interventions

DRUG

Tamsulosin

Subjects randomized to the experimental arm will receive a single dose of 0.4mg Tamsulosin tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

DRUG

Placebo

Subjects randomized to the control arm will receive a single dose of a placebo tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-05-02
Completion
2024-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05753670 on ClinicalTrials.gov