RECRUITING

Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-02-26
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06257576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Male and age ≥50 years
  3. * Deemed physically fit for surgery
  1. * Inability to obtain informed consent
  2. * Age \<50 years
  3. * Female
  4. * Baseline creatinine \>1.5x upper limit of normal
  5. * Tamsulosin therapy as a home-medication
  6. * Procedure involving the prostate, bladder, ureters, or kidneys
  7. * Planned Foley catheter removal on the same day of surgery
  8. * Planned nasogastric tube retention on postoperative day 1
  9. * Individuals taking daily phosphodiesterase 5 (PDE5) inhibitors (due to the risk of symptomatic hypotension if given with tamsulosin)

Contacts and Locations

Study Contact

Shishir K Maithel, MD
CONTACT
404-778-5777
smaithe@emory.edu

Principal Investigator

Shishir K Maithel, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital (EUH)
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Shishir K Maithel, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-26
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-02-26
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Postoperative Urinary Tract Infection