NCT04682366

The Effect of Tamsulosin on Postoperative Urinary Retention

Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.

Detailed description

The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned. Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo. Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.

Conditions

• Urinary Retention

Interventions

Type	Name	Description
DRUG	Tamsulosin	Oral drug: 10 days of 0.4 mg of oral Tamsulosin
DRUG	Placebo	Oral drug: 10 days of identical-appearing placebo

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2020-12-23
• Last updated: 2024-01-31
• Results posted: 2024-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study