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

February 23, 2021 updated by: McMaster University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tamsulosin Hydrochloride (HCL)
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.
Drug: Tamsulosin Hydrochloride

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of post-operative urinary retention (POUR)
Time Frame: 0-24 hours
Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period.
0-24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate and number of straight catheterizations
Time Frame: 0-7 days
Rate and number of straight catheterizations
0-7 days
Rate of indwelling catheterization
Time Frame: 0-7 days
Rate of indwelling catheterization
0-7 days
Time to first catheterization
Time Frame: 0-24 hours
Time to first catheterization
0-24 hours
Treatment emergent Adverse Events
Time Frame: -3 days to 2 days
Treatment emergent Adverse Events as reported by the FDA (the Federal Drug Administration )
-3 days to 2 days
Rates of catheter complications within 30 days of catheterization
Time Frame: 0 to 30 days
e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture
0 to 30 days
Duration of hospital length of stay
Time Frame: 0 to 365 days
Date of admission to date of discharge
0 to 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Yaron Shargall, MD, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 30, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (ACTUAL)

November 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJHH_REPOURT_P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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