Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial (PrePOURTS)

The objectives 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 pulmonary surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Retention Postoperative
• Intervention / Treatment: Drug: Tamsulosin Hydrochloride; Other: Placebo

Detailed Description

This study will evaluate the effectiveness of providing preoperative tamsulosin as prophylaxis against postoperative urinary retention after thoracic surgery. Participants will initiate prophylaxis 3 days prior to their study date and continue for 2 days postoperatively. This will be a placebo controlled double masked randomized trial. The primary outcome being evaluated is development of urinary retention; defined as required urinary catheterization. Secondary outcomes will include rate of straight catheterizations, indwelling catheterizations and time to catheterization.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Deb Lewis; Phone Number: 75685 519-685-8500; Email: deb.lewis@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria ( 2 or more of the following risk factors):

• Male Sex
• Age greater than or equal to 40 years
• History of Diabetes Mellitus
• Prior pelvic irradiation
• Use of indwelling Thoracic Epidural analgesia
• Prior history of urinary retention

AND

International Prostate Specific Score greater than or equal to 1.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 3 days pre-op, 2 days post-op
Experimental: Treatment; Tamsulosin	Drug: Tamsulosin Hydrochloride; 3 days pre-op, 2 days post-op; Other Names: tamsulosin HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of post operative urinary retention	defined as requiring straight or indwelling catheterization at any point in the post-operative period	30 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Straight Catheterizations	Number of Single urinary catheterizations performed	30 days post-op
Rate of Indwelling Catheterizations	Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay	30 days post-op
Time to first catheterization	Time to first catheterization	up to 30 days post-op
Treatment Related Adverse Events	Unexpected or noxious events that occur as a result of or suspected to be a result of use of the study drug.	30 days post-op
Catheter related complications	Rates of catheter related complications within 30 days of catheterization (e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture)	30 days post-op
Length of stay	Duration of hospital length of stay will be measured by collecting the date of admission and the date of discharge	30 days post-op

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Rahul Nayal, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Estimated): February 15, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: thoracic surgery; urinary retention; urinary catheter
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: PrePOURTS

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
• product manufactured in and exported from the U.S.: No