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

Early Phase 1

Active, not recruiting

• Conditions: Urinary Retention
• Interventions: Drug: Tamsulosin 0.4Mg Capsule; Drug: Placebo oral tablet

• Registration Number: NCT04232683
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Study Timeline

• Study Start: 2019-12-18
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-10-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure.

ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings

Exclusion Criteria

i. Diagnosis of urinary retention preoperatively (post void residual >150ml)

ii. Malignancy

iii. History of neurological disease

iv. History of spinal cord injuries

v. Allergy to Tamsulosin

vi. Perioperative complications requiring prolonged postoperative bladder drainage

vii. Incontinence procedures other than mid-urethral slings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative Tamsulosin	Tamsulosin 0.4Mg Capsule	The study group will receive one oral dose .4mg of Tamsulosin prior to surgery.
Preoperative Placebo	Placebo oral tablet	The control group will receive one oral dose of placebo pill prior to surgery.

Primary Outcome Measures

Name	Time	Method
Tamsulosin Effect	Up to 4 hours after surgery while patient is in post-anesthesia care unit.	Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively.

Secondary Outcome Measures

Name	Time	Method
Postoperative Narcotic Use	Up to 4 hours after surgery while patient is in post-anesthesia care unit.	Amount of postoperative narcotic use will be tracked to assess if increased narcotic use has an effect on postoperative voiding trial (The amount of narctoic use will be measured in milligrams)
Effect of Tamsulosin on postoperative blood pressure	Up to 4 hours after surgery while patient is in post-anesthesia care unit	A side effect of Tamsulosin in hypotension, therefore, postoperative blood pressure will be evaluated to see if Tamsulosin had a significant impact on blood pressure

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States