NCT03609580 Post-operative Urinary Retention (POUR) Following Thoracic Surgery
| NCT ID | NCT03609580 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hackensack Meridian Health |
| Condition | Urinary Retention |
| Study Type | INTERVENTIONAL |
| Enrollment | 127 participants |
| Start Date | 2018-05-07 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 127 participants in total. It began in 2018-05-07 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.
Eligibility 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)
Contact & Investigator
Daniel Mansour, MD
PRINCIPAL INVESTIGATOR
Hackensack Meridian Health
Frequently Asked Questions
Who can join the NCT03609580 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Urinary Retention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03609580 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03609580 currently recruiting?
Yes, NCT03609580 is actively recruiting participants. Contact the research team at daniel.mansour@hmhn.org for enrollment information.
Where is the NCT03609580 trial being conducted?
This trial is being conducted at Hackensack, United States.
Who is sponsoring the NCT03609580 clinical trial?
NCT03609580 is sponsored by Hackensack Meridian Health. The principal investigator is Daniel Mansour, MD at Hackensack Meridian Health. The trial plans to enroll 127 participants.