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Completed

NCT Number: NCT04232683

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention 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.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin 0.4Mg Capsule

Drug

Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased

Placebo oral tablet

Drug

Placebo pill given preoperatively

Other names: Preoperative Placebo

Primary outcomes

  1. Tamsulosin Effect

    Time frame: 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 outcomes

  1. Postoperative Narcotic Use

    Time frame: 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)

  2. Effect of Tamsulosin on postoperative blood pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2020
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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