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

Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility Trial

The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery.

Study Overview

• Status: Recruiting
• Conditions: Urinary Retention Postoperative
• Intervention / Treatment: Drug: Tamsulosin Hydrochloride; Other: Placebo

Detailed Description

The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery. Primary outcomes being measured are the enrollment rate, protocol adherence rate and participant drop out.

• Study Type: Interventional
• Enrollment (Estimated): 60
• 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
      • Recruiting
      • London Health Sciences Centre
      • Contact: Rahul Nayak, MD MSc; Phone Number: 56927 519-685-8500; Email: rahul.nayak@lhsc.on.ca

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
• Nursing/ Breastfeeding women
• Use of intraoperative bladder catheter
• patients for whom cataract and/or glaucoma surgery is scheduled.
• patients on strong inhibitors of CYP3A4 (e.g., ketoconazole), on moderate inhibitors of CYP3A4 (e.g., erythromycin), on strong (e.g. paroxetine), on moderate (e.g., terbinafine) inhibitors of CYP2D6 or in patients known to be CYP2D6 poor metabolizers.
• patients with a serious or life-threatening sulfa allergy
• patients with severe hepatic insufficiency
• patients with severe renal impairment (creatinine clearance of <10 mL/min)
• patients with a serious or life-threatening sulfa allergy

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; 2 days pre-op, day of surgery, 2 days post-op
Experimental: Treatment; Tamsulosin	Drug: Tamsulosin Hydrochloride; 2 days pre-op, day of surgery, 2 days post-op; Other Names: tamsulosin HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Effectiveness	Percentage of Screen eligible patients consenting to the study	4 months
Monthly recruitment	Rate of monthly recruitment	4 months
Protocol adherence	Percentage of enrolled patient adherent to protocol during intervention phase	4 Months

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 (Actual): October 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: thoracic surgery; urinary retention; urinary catheter
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Adrenergic Agents; Urological Agents; Adrenergic Antagonists; 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