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

Phase 3

• Conditions: Urinary Catheterization; Thoracic Surgery; Thoracic Epidural Analgesia
• Interventions: Drug: Placebos; Drug: Tamsulosin Hydrochloride

• Registration Number: NCT04159077
• Lead Sponsor: McMaster University

Brief 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.

Study Timeline

• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25
• Study Start: 2021-07-30
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery.
Tamsulosin Hydrochloride (HCL)	Tamsulosin Hydrochloride	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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