Back to resultsPost-operative Urinary Retention (POUR) Following Thoracic Surgery (POUR)
Primary Purpose
Urinary Retention
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin - 1 week
Tamsulosin - 3 days
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention focused on measuring post operative urinary retention, inability to urinate, urinary retentions, lung cancer, VATs, Robotic Lung Surgery, lung resections
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria:
Males
≥60 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
Patient eligibility criteria should be listed. (Medical criteria, age, demonstration of disease, ailment, etc., proof of failure using standard therapy, laboratory assessments for eligibility, etc.).
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)
Sites / Locations
- Daniel MansourRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 week Pre-operative Tamsulosin administration
3 days Pre-operative Tamsulosin administration
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03609580
First Posted
July 12, 2018
Last Updated
August 25, 2023
Sponsor
Hackensack Meridian Health
1. Study Identification
Unique Protocol Identification Number
NCT03609580
Brief Title
Post-operative Urinary Retention (POUR) Following Thoracic Surgery
Acronym
POUR
Official Title
Post-operative Urinary Retention (POUR) Following Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
May 2, 2024 (Anticipated)
Study Completion Date
May 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
post operative urinary retention, inability to urinate, urinary retentions, lung cancer, VATs, Robotic Lung Surgery, lung resections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
127 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 week Pre-operative Tamsulosin administration
Arm Type
Experimental
Arm Title
3 days Pre-operative Tamsulosin administration
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tamsulosin - 1 week
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin - 3 days
Intervention Description
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 Information:
Title
Volume of urine (cc) post thoracic surgery in patients that received Flomax, 0.4mg/day for a week before surgery
Description
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
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Mansour, MD
Phone
551-996-2000
Ext
5960
Email
daniel.mansour@hmhn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Mansour, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daniel Mansour
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Mansour, MD
Phone
551-996-2000
Ext
5960
Email
daniel.mansour@hmhn.org
First Name & Middle Initial & Last Name & Degree
Daniel Mansour, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-operative Urinary Retention (POUR) Following Thoracic Surgery
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