Preventing urinary retention after thoracic surgery in older men
Post-operative Urinary Retention (POUR) Following Thoracic Surgery
This study tests if giving Tamsulosin before and after thoracic surgery can help older men avoid urinary retention and the need for catheters.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 127 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Hackensack Meridian Health Academic / other |
| Locations | 1 site (Hackensack, New Jersey) |
| Trial ID | NCT03609580 on ClinicalTrials.gov |
What this trial studies
This study aims to reduce the incidence of post-operative urinary retention (POUR) in older men undergoing thoracic surgery by administering Tamsulosin (Flomax) before and after the procedure. The medication is intended to relax the prostate and improve urinary flow, potentially preventing the need for uncomfortable catheterization. The study will involve male participants aged 50 and older who are scheduled for minimally invasive thoracic surgeries. The effectiveness of Tamsulosin will be evaluated by comparing the rates of urinary retention in those receiving the medication versus standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are males aged 50 and older who are scheduled for minimally invasive thoracic surgical procedures.
Not a fit: Patients who are already using Flomax, have certain medical conditions, or have undergone prostate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce urinary retention complications, leading to improved patient comfort and shorter hospital stays.
How similar studies have performed: Other studies have indicated that pre-operative use of medications like Tamsulosin can be effective in reducing urinary retention, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Males ≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 3 days from the time of consent Exclusion Criteria: * Using Flomax already * Allergy to Flomax or sulfa drugs * Current use of alpha blockers or alpha agonists * Resting systolic blood pressure \<100 * Orthostatic hypotension of \>20mm Hg (millimeters of mercury) Systolic and/or 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent * Known diagnosis of congestive heart failure and valvular heart disease * History of prostate surgery (prostatectomy, trans-urethral resection)
Where this trial is running
Hackensack, New Jersey
- Daniel Mansour — Hackensack, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Mansour, MD — Hackensack Meridian Health
- Study coordinator: Daniel Mansour, MD
- Email: daniel.mansour@hmhn.org
- Phone: 551-996-2000
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.