NCT04159077

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Catheterization
• Thoracic Surgery
• Thoracic Epidural Analgesia

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-11-12
• Last updated: 2021-02-25