Post-operative Urinary Retention (POUR) Following Thoracic Surgery

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT03609580
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Urinary Retention

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 7, 2018
Status verified
Jun 2026
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
127 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1 week Pre-operative Tamsulosin administration
  • Experimental: 3 days Pre-operative Tamsulosin administration

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

Locations (1)

FacilityCityStateZIPSite coordinators
Michael SpalloneHackensackNew Jersey07601
Michael Spallone, MD
[email protected]
551-996-2000
Michael Spallone, MD (PRINCIPAL_INVESTIGATOR)

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