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Post-operative Urinary Retention (POUR) Following Thoracic Surgery (POUR)

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ClinicalTrials.gov Identifier: NCT03609580
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

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.

Condition or disease Intervention/treatment Phase
Urinary Retention Drug: Tamsulosin Phase 1 Phase 2

Detailed Description:

Post-operative urinary retention (POUR) in older men who undergo a thoracic surgical procedure occurs in a significant proportion of patients (25% at Hackensack University Medical Center in men >60) and is a significant management problem. Typically, this complication needs to be treated with placement of a bladder catheter (foley). In addition to the discomfort of placing a foley in an awake patient, these patients are at a significantly increased risk of a catheter associated urinary tract infection (CAUTI), potential genito-urinary injury during the placement, and bladder muscle damage due to distention.

The goal of this study is to investigate whether the use of Tamusolin could lower the high incidence of POUR in older men undergoing a thoracic surgical procedure.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-operative Urinary Retention (POUR) Following Thoracic Surgery
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : May 2, 2020
Estimated Study Completion Date : May 2, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Tamsulosin
    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.


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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males
  • ≥65 years old
  • Planned surgical procedure of a video assisted thoracoscopic surgery (wedge resection, lobectomy, pleural biopsy, or pleurodesis)
  • Surgery scheduled more than 7 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609580


Contacts
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Contact: Angelina Dennis 551-996-2000 ext 75520 angelina.dennis@hackensackmeridian.org

Locations
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United States, New Jersey
HackensackUMC Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Angelina Dennis    551-996-2000 ext 75520    angelina.dennis@hackensackmeridian.org   
Principal Investigator: Nabil P Rizk         
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: Nabil Rizk Hackensack Meridian Health

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT03609580     History of Changes
Other Study ID Numbers: PRO#2017-0687
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hackensack Meridian Health:
post operative urinary retention
inability to urinate
urinary retentions
lung cancer
VATs
Robotic Lung Surgery
lung resections

Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents