Post-operative Urinary Retention (POUR) Following Thoracic Surgery

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age50+
SponsorHackensack Meridian Health

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Using Flomax already

Allergy to Flomax or sulfa drugs

Current use of alpha blockers or alpha agonists

Resting systolic blood pressure <100

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

127 Participants
are divided into 2 treatment groups
Group A: 1 week Pre-operative Tamsulosin administrationExperimental treatment 1 intervention
Group B: 3 days Pre-operative Tamsulosin administrationExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
8 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.