NCT04232683

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.

Detailed description

This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.

Conditions

• Urinary Retention

Interventions

Type	Name	Description
DRUG	Tamsulosin 0.4Mg Capsule	Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased
DRUG	Placebo oral tablet	Placebo pill given preoperatively

Timeline

• Start date: 2019-12-18
• Primary completion: 2025-10-11
• Completion: 2025-12-01
• First posted: 2020-01-18
• Last updated: 2025-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study