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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Retention
• Intervention / Treatment: Drug: Tamsulosin 0.4Mg Capsule; Drug: Placebo oral tablet

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative Tamsulosin; The study group will receive one oral dose .4mg of Tamsulosin prior to surgery.	Drug: Tamsulosin 0.4Mg Capsule; Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased
Placebo Comparator: Preoperative Placebo; The control group will receive one oral dose of placebo pill prior to surgery.	Drug: Placebo oral tablet; Placebo pill given preoperatively; Other Names: Preoperative Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Narcotic Use	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)	Up to 4 hours after surgery while patient is in post-anesthesia care unit.
Effect of Tamsulosin on postoperative blood pressure	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	Up to 4 hours after surgery while patient is in post-anesthesia care unit

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): October 11, 2025
• Study Completion (Actual): October 11, 2025

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Tamsulosin; Female Pelvic Floor Disorders; Postoperative Urinary Retention
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Tamsulosin
• Other Study ID Numbers: FLA 19-073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes