Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter

Postoperative Urinary Tract Infection Clinical Trial

— FOLI  

Official title:

Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257576
• Other study ID #: STUDY00006810
• Status: Recruiting
• Phase: Phase 3
• Start date: February 26, 2024
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: Emory University
• Contact: Shishir K Maithel, MD
• Phone: 404-778-5777
• Email: smaithe[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: August 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Postoperative Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital (EUH)	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	ABRAHAM J & PHYLLIS KATZ FOUNDATION

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with catheter-associated urinary tract infections (CAUTI),	Participants who develop CAUUTI, defined by positive urinary analysis (UA) or bacterial culture >100,000 colony-forming units (CFUs), within the first 5 days following surgery or until hospital discharge, whichever comes first.	Up to 5 days post-surgery