Impact of Tamsulosin on Urinary Complications in Older Men After Surgery
Function of Tamsulosin in Older Males Undergoing Surgery with Indwelling Catheter: a Randomized Clinical Trial
This study is testing if the medication tamsulosin can help older men avoid urinary problems and infections after surgery on their liver, gallbladder, pancreas, colon, or rectum.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Emory University Academic / other |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT06257576 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of tamsulosin, a medication commonly used to treat urinary issues, on the incidence of postoperative urinary retention (POUR) and catheter-associated urinary tract infections (CAUTI) in older males undergoing elective surgeries involving the liver, gallbladder, pancreas, colon, or rectum. Participants will receive either tamsulosin or a control treatment after surgery, and their urinary function will be monitored following the removal of an indwelling Foley catheter. The study aims to determine if tamsulosin can reduce the discomfort and complications associated with urinary retention and infections post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are males aged 50 years and older who are scheduled for elective surgery involving the liver, gallbladder, pancreas, colon, or rectum.
Not a fit: Patients who are under 50 years old, female, or have specific urinary tract conditions or contraindications to tamsulosin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of urinary complications and improve recovery experiences for older male surgical patients.
How similar studies have performed: Previous studies have shown promising results with tamsulosin in managing urinary retention, suggesting that this approach may be beneficial, although this specific application is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital (EUH) — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth Cardona, MD — Emory University
- Study coordinator: Kenneth Cardona, MD
- Email: kcardon@emory.edu
- Phone: 404-686-3203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.