Recruiting
Phase 1
Phase 2

Flomax

Sponsor:

Hackensack Meridian Health

Code:

NCT03609580

Conditions

Urinary Retention

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Accepted

Interventions

Tamsulosin - 1 week

Tamsulosin - 3 days

Study Details

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.

Conditions

Urinary Retention

Study ID

NCT03609580

Start date

May 7, 2018

Status verified date

Jun, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

127 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1 week Pre-operative Tamsulosin administration

experimental: 3 days Pre-operative Tamsulosin administration

Interventions

Tamsulosin - 1 week

The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.

Tamsulosin - 3 days

The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 3 days), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.

Primary outcome measure

  • Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery [ Time Frame: 8 hours ]

Central Contacts and Locations

Central contacts

Michael Spallone, MD

551-996-2000michael.spallone@hmhn.org

Locations

Michael Spallone

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Michael Spallone, MD

551-996-2000michael.spallone@hmhn.org

Principal Investigator:

Michael Spallone, MD

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • post operative urinary retention
  • inability to urinate
  • urinary retentions
  • lung cancer
  • VATs
  • Robotic Lung Surgery
  • lung resections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-06-11.