Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

NCT06262048 | Recruiting Phase 2 DMC

• 1 other identifier: PrePOURTS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Retention Postoperative

Keywords

urinary retention; thoracic surgery; urinary catheter

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Rate of Straight Catheterizations

  30 days post-op

• Rate of Indwelling Catheterizations

  30 days post-op

• Time to first catheterization

  up to 30 days post-op

• Treatment Related Adverse Events

  30 days post-op

• Catheter related complications

  30 days post-op

Study Arms (2)

Treatment

EXPERIMENTAL

Tamsulosin

Drug: Tamsulosin Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Tamsulosin Hydrochloride DRUG

2 days pre-op, day of surgery, 2 days post-op

Also known as: tamsulosin HCL

Treatment

Placebo OTHER

2 days pre-op, day of surgery, 2 days post-op

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Urinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Rahul Nayal

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deb Lewis

CONTACT

519-685-8500; deb.lewis@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc FRCSC

Model Details: single centre, double blind randomized controlled trial

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 15, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: February 1, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)