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

Thoracic Surgery Clinical Trial

— REPOURT-P  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04159077
• Other study ID #: SJHH_REPOURT_P
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 30, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: McMaster University
• Contact: Housne Begum, PhD
• Phone: (905)522-1155
• Email: begumh[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Epidural Analgesia
• Thoracic Surgery
• Urinary Catheterization
• Urinary Retention

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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:CD009121. doi: 10.1002/14651858.CD009121.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of post-operative urinary retention (POUR)	Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period.	0-24 hours
Secondary	Rate and number of straight catheterizations	Rate and number of straight catheterizations	0-7 days
Secondary	Rate of indwelling catheterization	Rate of indwelling catheterization	0-7 days
Secondary	Time to first catheterization	Time to first catheterization	0-24 hours
Secondary	Treatment emergent Adverse Events	Treatment emergent Adverse Events as reported by the FDA (the Federal Drug Administration )	-3 days to 2 days
Secondary	Rates of catheter complications within 30 days of catheterization	e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture	0 to 30 days
Secondary	Duration of hospital length of stay	Date of admission to date of discharge	0 to 365 days