Clinical trial NCT04159077: REduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial
Official title: Reduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Urinary Catheterization
Thoracic Surgery
Thoracic Epidural Analgesia
Keywords: Post-operative urinary retention
Tamsulosin
urinary tract infections
catheter
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 350
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of post-operative urinary retention (POUR)
timeFrame: 0-24 hours
Secondary outcomes:
measure: Rate and number of straight catheterizations
timeFrame: 0-7 days
measure: Rate of indwelling catheterization
timeFrame: 0-7 days
measure: Time to first catheterization
timeFrame: 0-24 hours
measure: Treatment emergent Adverse Events
timeFrame: -3 days to 2 days
measure: Rates of catheter complications within 30 days of catheterization
timeFrame: 0 to 30 days
measure: Duration of hospital length of stay
timeFrame: 0 to 365 days
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Yaron Shargall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
citation: Kim KW, Lee JI, Kim JS, Lee YJ, Choi WJ, Jung H, Park KY, Park CH, Son KH. Risk factors for urinary retention following minor thoracic surgery. Interact Cardiovasc Thorac Surg. 2015 Apr;20(4):486-92. doi: 10.1093/icvts/ivu445. Epub 2015 Jan 6.
citation: Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018 Aug 1;178(8):1078-1085. doi: 10.1001/jamainternmed.2018.2417.
citation: Shokrpour M, Shakiba E, Sirous A, Kamali A. Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery. J Family Med Prim Care. 2019 Feb;8(2):722-727. doi: 10.4103/jfmpc.jfmpc_18_19.
citation: Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017.