Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter

NCT06257576 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY000068102025P010592
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

Brief Summary

This study is being done to answer the question: What is the impact of a medication called tamsulosin (also called Flomax) on the rate of postoperative urinary retention (POUR) and catheter-associated urinary tract infection (UTI)? One of the most common complications following surgery and associated with Foley catheters is post-operative urinary retention (POUR) after the catheter is removed. This is defined as being unable to urinate spontaneously within 8 hours following the removal of the indwelling Foley catheter (the catheter that sits in your bladder to drain urine after surgery). When this happens, it requires intermittent straight catheterization of the bladder (placing a temporary catheter in the bladder to drain the buildup of urine), which can cause a lot of discomfort and anxiety, as well as increase the risk of catheter-associated urinary tract infection (CAUTI).

Conditions

Postoperative Urinary Tract Infection

Keywords

post-operative urinary retention (POUR); catheter-associated urinary tract infection (CAUTI); Flomax; Foley Catheter

Outcome Measures

Primary Outcomes (1)

• Number of participants who develop postoperative urinary retention (POUR) postoperatively (efficacy).

  Researchers will document the incidence of postoperative urinary retention (POUR) rate, as defined as the inability to void within 8 hours after Foley catheter removal at midnight on postoperative day 1.

  Up to 3 days post-surgery

Secondary Outcomes (1)

• Number of participants with catheter-associated urinary tract infections (CAUTI),

  Up to 5 days post-surgery

Study Arms (2)

Tamusolin

EXPERIMENTAL

Participants will receive tamsulosin postoperatively for two days.

Drug: Tamsulosin

Control Group

OTHER

Participants will be randomized to the standard of care, with no medication given.

Other: Control Group

Interventions

Tamsulosin DRUG

Tamsulosin is a selective antagonist at alpha-1A and alpha-1B-adrenoreceptors in the prostate, prostatic capsule, prostatic urethra, and bladder neck. Blockage of the alpha-1A receptors causes relaxation of smooth muscles in the bladder neck and prostate, thus decreasing urinary outflow resistance in men. Tamsulosin will be administered twice a day for two (2) days as an oral tablet containing 0.4 mg of the drug. It is usually administered 30 minutes after a meal to minimize plasma level variations. The 0.4 mg dose of tamsulosin that will be used in this trial has shown adequate safety and tolerability in multiple previously published studies as well as efficacy in treating benign prostatic hyperplasia (BPH) and lower urinary tract symptoms in men. A Foley catheter, which will be placed for the participant's surgical procedure regardless of enrollment in the study, will be removed at midnight on postoperative day 1.

Also known as: Flomax

Tamusolin

Control Group OTHER

A Foley catheter, which will be placed for the participant's surgical procedure regardless of enrollment in the study, will be removed at midnight on postoperative day 1.

Also known as: Standard of Care (SOC)

Control Group

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: The investigational product (IP)Tamsulosin is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for elective surgery for any reason (benign, malignant, or indeterminate lesion) with either an open or minimally invasive approach (hepatobiliary, pancreatic, and colorectal operations)
• Male and age ≥50 years
• Deemed physically fit for surgery

You may not qualify if:

• Inability to obtain informed consent
• Age \<50 years
• Female
• Baseline creatinine \>1.5x upper limit of normal
• Tamsulosin therapy as a home-medication
• Procedure involving the prostate, bladder, ureters, or kidneys
• Planned Foley catheter removal on the same day of surgery
• Planned nasogastric tube retention on postoperative day 1
• Individuals taking daily phosphodiesterase 5 (PDE5) inhibitors (due to the risk of symptomatic hypotension if given with tamsulosin)

Sponsors & Collaborators

• Emory University: lead
• ABRAHAM J & PHYLLIS KATZ FOUNDATION: collaborator

Study Sites (4)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital (EUH)

Atlanta, Georgia, 30322, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Interventions

Tamsulosin; Control Groups; Standard of Care

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kenneth Cardona, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: February 26, 2024
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: The Investigator will share the NSQIP de-identified data for a secondary analysis of the data upon request.

Locations

US (4)