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Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin (POUR)

Primary Purpose

Thoracic Diseases, Urinary Retention

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tamsulosin Hydrochloride
Sponsored by
Feiran Lou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Diseases

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All male patients >=60 years old who undergo inpatient thoracic surgery for major resections.

Exclusion Criteria:

  • - Prisoners
  • Adults unable to consent
  • End stage renal disease on hemodialysis
  • Indwelling urinary catheter
  • Child-Pugh class C hepatic failure
  • Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine
  • patients known to be CYP2D6 poor metabolizers
  • History of prostatectomy or cystectomy
  • Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks

Sites / Locations

  • UMass Memorial Healthcare, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Perioperative Tamsulosin Hydrochloride

Historical Comparator

Arm Description

Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery.

Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.

Outcomes

Primary Outcome Measures

Participants with Post-Operative Urinary Retention (Pour)
Percentage of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery

Secondary Outcome Measures

Full Information

First Posted
July 29, 2021
Last Updated
May 23, 2023
Sponsor
Feiran Lou
Collaborators
UMass Memorial Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT04994431
Brief Title
Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin
Acronym
POUR
Official Title
Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Feiran Lou
Collaborators
UMass Memorial Health Care

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
Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.
Detailed Description
Post-operative urinary retention (POUR) is one of the most common post-operative complications encountered by most surgical specialties. The incidence of POUR can vary from five to 70%. Post-operative urinary retention is a prevalent complication. Patients who undergo thoracic surgery have greater urinary retention rates compared to others. Data on effective methods to reduce the risk of POUR in this high-risk group are limited. All subjects who meet inclusion and exclusion criteria will be invited to participate. There will be no randomization. All will receive tamsulosin in the pre operative period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases, Urinary Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
All subjects that sign a study consent and meet inclusion and exclusion criteria will receive the the study drug.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perioperative Tamsulosin Hydrochloride
Arm Type
Experimental
Arm Description
Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery.
Arm Title
Historical Comparator
Arm Type
No Intervention
Arm Description
Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin Hydrochloride
Intervention Description
0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.
Primary Outcome Measure Information:
Title
Participants with Post-Operative Urinary Retention (Pour)
Description
Percentage of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery
Time Frame
5 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All male patients >=60 years old who undergo inpatient thoracic surgery for major resections. Exclusion Criteria: - Prisoners Adults unable to consent End stage renal disease on hemodialysis Indwelling urinary catheter Child-Pugh class C hepatic failure Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine patients known to be CYP2D6 poor metabolizers History of prostatectomy or cystectomy Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feiran Lou, MD
Phone
509-334-8996
Email
feiran.lou@umassmemorial.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shauneen Valliere, MSN
Phone
5083175205
Email
shauneen.valliere@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feiran Lou, MD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Healthcare, Inc.
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data

Learn more about this trial

Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin

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