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

NCT04159077 | Unknown Phase 3 DMC

• 1 other identifier: SJHH_REPOURT_P
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Catheterization; Thoracic Surgery; Thoracic Epidural Analgesia

Keywords

Post-operative urinary retention; Tamsulosin; urinary tract infections; catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate and number of straight catheterizations

  0-7 days

• Rate of indwelling catheterization

  0-7 days

• Time to first catheterization

  0-24 hours

• Treatment emergent Adverse Events

  -3 days to 2 days

• Rates of catheter complications within 30 days of catheterization

  0 to 30 days

Study Arms (2)

Tamsulosin Hydrochloride (HCL)

EXPERIMENTAL

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.

Drug: Tamsulosin Hydrochloride

Placebo

PLACEBO COMPARATOR

Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery.

Drug: Placebos

Interventions

Tamsulosin Hydrochloride DRUG

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

Tamsulosin Hydrochloride (HCL)

Placebos DRUG

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.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively

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

Sponsors & Collaborators

• McMaster University: lead

Related Publications (5)

• 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.

  PMID: 26897642 BACKGROUND

• 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.

  PMID: 25564576 BACKGROUND

• 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.

  PMID: 29971436 BACKGROUND

• 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.

  PMID: 30984702 BACKGROUND

• 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.

  PMID: 28584678 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Infections; 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

• Yaron Shargall, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Housne Begum, PhD

CONTACT

(905)522-1155; begumh@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: July 30, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share