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Phase 3 N=179 Randomized Quadruple-blind Prevention

Effect of Preoperative Tamsulosin on Postoperative Urinary Retention

Postoperative Retention of Urine

Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Number of Participants With Postoperative Urinary Retention — 14; 16 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Tamsulosin (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Endeavor Health
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Postoperative Urinary Retention
14; 16
SECONDARY
Number of Participants With Postoperative Urinary Tract Infection (UTI)
1; 1
SECONDARY
Number of Participants With Unplanned Admission or Unplanned Healthcare Encounter
6; 4
SECONDARY
Number of Participants With Postoperative Hypotension or Syncope
2; 0

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.

Eligibility Criteria

Inclusion Criteria

  • Mid-urethral sling placement

Exclusion Criteria

  • Age <18
  • Planned combined cases with colorectal surgery, general surgery, or gynecology-oncology
  • Planned sling revision or history of prior sling placement
  • Known history of urinary retention
  • Concomitant intravesical botulinum injections
  • Known contraindication to tamsulosin
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05753670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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