Post-operative Urinary Retention (POUR) Following Thoracic Surgery

NCT03609580 | Recruiting Phase 1 FDA Drug

• 1 other identifier: PRO#2017-0687
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery

  The absence of voiding naturally after undergoing thoracic surgery needing an intervention as a Foley catheter or a catheterization. Documentation for first void, Post bladder scan showing more that 300cc of residual urine in the bladder (failure to urinate), or following spontaneous urination if there is more than 300cc of residual urine in the bladder (inadequate urination)

  8 hours

Study Arms (2)

1 week Pre-operative Tamsulosin administration

EXPERIMENTAL

Drug: Tamsulosin - 1 week

3 days Pre-operative Tamsulosin administration

EXPERIMENTAL

Drug: Tamsulosin - 3 days

Interventions

Tamsulosin - 1 week DRUG

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.

1 week Pre-operative Tamsulosin administration

Tamsulosin - 3 days DRUG

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.

3 days Pre-operative Tamsulosin administration

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Daniel Mansour

Hackensack, New Jersey, 07601, United States

RECRUITING

MeSH Terms

Conditions

Urinary Retention; Lung Neoplasms

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Daniel Mansour, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Mansour, MD

CONTACT

551-996-2000; daniel.mansour@hmhn.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 1, 2018
• Study Start: May 7, 2018
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)