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

NCT04232683 | Completed Early Phase 1 FDA Drug

• 1 other identifier: FLA 19-073
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Keywords

Female Pelvic Floor Disorders; Postoperative Urinary Retention; Tamsulosin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative Narcotic Use

  Up to 4 hours after surgery while patient is in post-anesthesia care unit.

• Effect of Tamsulosin on postoperative blood pressure

  Up to 4 hours after surgery while patient is in post-anesthesia care unit

Study Arms (2)

Preoperative Tamsulosin

EXPERIMENTAL

The study group will receive one oral dose .4mg of Tamsulosin prior to surgery.

Drug: Tamsulosin 0.4Mg Capsule

Preoperative Placebo

PLACEBO COMPARATOR

The control group will receive one oral dose of placebo pill prior to surgery.

Drug: Placebo oral tablet

Interventions

Tamsulosin 0.4Mg Capsule DRUG

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

Preoperative Tamsulosin

Placebo oral tablet DRUG

Placebo pill given preoperatively

Also known as: Preoperative Placebo

Preoperative Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 18, 2020
• Study Start: December 18, 2019
• Primary Completion: October 11, 2025
• Study Completion: October 11, 2025
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)