Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter

NCT ID: NCT06257576

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2026-02-28

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).

Detailed Description

All participants in this study will be males who are undergoing a planned surgery on their liver, gallbladder/biliary tract, pancreas, colon, or rectum for any reason. If able to obtain appropriate consent from a legal representative, cognitively impaired patients may be included. After having surgery where a catheter is placed in the bladder to drain urine (this is called a Foley indwelling catheter), the catheter eventually gets removed, and some of the most frequent problems that can happen after that are post-operative urinary retention (POUR) and catheter-associated urinary tract infection (CAUTI).

The goal of this study is to see if a medicine called tamsulosin (also called Flomax) can decrease the rate of POUR, which means not being able to urinate spontaneously like normal, and CAUTI, which means an infection in the urinary tract. This study is important because POUR and CAUTI can cause harm to patients, including discomfort if a temporary catheter has to be placed back in the bladder to get the urine out, infection, anxiety, and stress, and it's known that these complications can also increase hospital charges.

Conditions

Postoperative Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tamusolin

Participants will receive tamsulosin postoperatively for two days.

Group Type: EXPERIMENTAL

Tamsulosin

Intervention Type: 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.

Control Group

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

Group Type: OTHER

Control Group

Intervention Type: 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.

Interventions

Tamsulosin

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.

Intervention Type: DRUG

Control Group

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.

Intervention Type: OTHER

Other Intervention Names

Flomax; Standard of Care (SOC)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ABRAHAM J & PHYLLIS KATZ FOUNDATION

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Cardona

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Cardona, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Hospital (EUH)

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kenneth Cardona, MD

Role: CONTACT

kcardon@emory.edu

404-686-3203

Facility Contacts

Kenneth Cardona, MD

Role: primary

kcardon@emory.edu

404-686-3203

Other Identifiers

STUDY00006810

Identifier Type: -

Identifier Source: org_study_id