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REduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial (REPOURT-P)

Primary Purpose

Urinary Catheterization, Thoracic Surgery, Thoracic Epidural Analgesia

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tamsulosin Hydrochloride
Placebos
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Catheterization focused on measuring Post-operative urinary retention, Tamsulosin, urinary tract infections, catheter

Eligibility Criteria

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

Inclusion Criteria:

  1. Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively.

    OR

  2. Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively

Exclusion Criteria:

  1. Active treatment of Benign Prostatic Hyperplasia (BPH)
  2. Hypersensitivity or allergy to tamsulosin HCL
  3. Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
  4. Active urinary tract infection
  5. History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy
  6. History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
  7. Underlying neurological disorders resulting in impaired bladder function
  8. Any known contraindication to the use of tamsulosin HCL

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tamsulosin Hydrochloride (HCL)

    Placebo

    Arm Description

    Consenting patients undergoing pulmonary resection will receive a 5-day allotment of tamsulosin HCL to be started 3 days prior to their date of surgery.

    Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery.

    Outcomes

    Primary Outcome Measures

    Rate of post-operative urinary retention (POUR)
    Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period.

    Secondary Outcome Measures

    Rate and number of straight catheterizations
    Rate and number of straight catheterizations
    Rate of indwelling catheterization
    Rate of indwelling catheterization
    Time to first catheterization
    Time to first catheterization
    Treatment emergent Adverse Events
    Treatment emergent Adverse Events as reported by the FDA (the Federal Drug Administration )
    Rates of catheter complications within 30 days of catheterization
    e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture
    Duration of hospital length of stay
    Date of admission to date of discharge

    Full Information

    First Posted
    November 7, 2019
    Last Updated
    February 23, 2021
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04159077
    Brief Title
    REduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial
    Acronym
    REPOURT-P
    Official Title
    Reduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing thoracic surgery.
    Detailed Description
    Post-operative urinary retention (POUR) is not an uncommon complication following thoracic surgery. It has been reported to occur in up to 12-67% of patients with the use of thoracic epidural analgesia1. Risk factors associated with urinary retention in thoracic patients include male, age over 40 years, type 2 diabetes, undergoing lung resection and the use of thoracic epidural analgesia2. Patients who experience urinary retention are treated with a straight catheter and may subsequently require the placement of an indwelling catheter. The use of these catheters is associated with numerous complications. The best studied complications are infectious and include catheter associated urinary tract infections (CAUTIs). However, many patients continue to experience symptoms well after their catheters have been removed. Tamsulosin is an alpha one adrenergic receptor blocked that is indicated for the treatment of lower urinary tract symptoms in the context of benign prostatic hyperplasia. However, it is often used in clinical practice to treat other pathologies such as acute urinary retention and nephrolithiasis. The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and catheter related complications in people undergoing thoracic surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Catheterization, Thoracic Surgery, Thoracic Epidural Analgesia
    Keywords
    Post-operative urinary retention, Tamsulosin, urinary tract infections, catheter

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tamsulosin Hydrochloride (HCL)
    Arm Type
    Experimental
    Arm Description
    Consenting patients undergoing pulmonary resection will receive a 5-day allotment of tamsulosin HCL to be started 3 days prior to their date of surgery.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin Hydrochloride
    Intervention Description
    Tamsulosin HCL is an alpha blocker. It relaxes the muscles in the prostate and bladder neck, making easier to urinate. The dosage used will be 0.4 mg (administered once daily) Other names: Flomax
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    Half of the patients will be assigned to receive placebo tablets in the same manner as the active intervention. These tablets will have no effect.
    Primary Outcome Measure Information:
    Title
    Rate of post-operative urinary retention (POUR)
    Description
    Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period.
    Time Frame
    0-24 hours
    Secondary Outcome Measure Information:
    Title
    Rate and number of straight catheterizations
    Description
    Rate and number of straight catheterizations
    Time Frame
    0-7 days
    Title
    Rate of indwelling catheterization
    Description
    Rate of indwelling catheterization
    Time Frame
    0-7 days
    Title
    Time to first catheterization
    Description
    Time to first catheterization
    Time Frame
    0-24 hours
    Title
    Treatment emergent Adverse Events
    Description
    Treatment emergent Adverse Events as reported by the FDA (the Federal Drug Administration )
    Time Frame
    -3 days to 2 days
    Title
    Rates of catheter complications within 30 days of catheterization
    Description
    e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture
    Time Frame
    0 to 30 days
    Title
    Duration of hospital length of stay
    Description
    Date of admission to date of discharge
    Time Frame
    0 to 365 days

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively. OR Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively Exclusion Criteria: Active treatment of Benign Prostatic Hyperplasia (BPH) Hypersensitivity or allergy to tamsulosin HCL Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date Active urinary tract infection History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy) Underlying neurological disorders resulting in impaired bladder function Any known contraindication to the use of tamsulosin HCL
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Housne Begum, PhD
    Phone
    (905)522-1155
    Ext
    35338
    Email
    begumh@mcmaster.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yaron Shargall, MD, PhD
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26897642
    Citation
    Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
    Results Reference
    background
    PubMed Identifier
    25564576
    Citation
    Kim KW, Lee JI, Kim JS, Lee YJ, Choi WJ, Jung H, Park KY, Park CH, Son KH. Risk factors for urinary retention following minor thoracic surgery. Interact Cardiovasc Thorac Surg. 2015 Apr;20(4):486-92. doi: 10.1093/icvts/ivu445. Epub 2015 Jan 6.
    Results Reference
    background
    PubMed Identifier
    29971436
    Citation
    Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018 Aug 1;178(8):1078-1085. doi: 10.1001/jamainternmed.2018.2417.
    Results Reference
    background
    PubMed Identifier
    30984702
    Citation
    Shokrpour M, Shakiba E, Sirous A, Kamali A. Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery. J Family Med Prim Care. 2019 Feb;8(2):722-727. doi: 10.4103/jfmpc.jfmpc_18_19.
    Results Reference
    background
    PubMed Identifier
    28584678
    Citation
    Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017.
    Results Reference
    background

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    REduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial

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