Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin

Phase 4

Terminated

• Conditions: Thoracic Diseases; Urinary Retention
• Interventions: Drug: Tamsulosin Hydrochloride

• Registration Number: NCT04994431
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.

Detailed Description

Post-operative urinary retention (POUR) is one of the most common post-operative complications encountered by most surgical specialties. The incidence of POUR can vary from five to 70%.

Post-operative urinary retention is a prevalent complication. Patients who undergo thoracic surgery have greater urinary retention rates compared to others. Data on effective methods to reduce the risk of POUR in this high-risk group are limited.

All subjects who meet inclusion and exclusion criteria will be invited to participate. There will be no randomization. All will receive tamsulosin in the pre operative period.

Study Timeline

• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Study Start: 2021-08-01
• Study First Posted: 2021-08-06
• Primary Completion: 2023-10-04
• Study Completion: 2023-10-04
• Results First Submitted: 2024-10-04
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Results First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 109

Inclusion Criteria

• All male patients >=60 years old who undergo inpatient thoracic surgery for major resections.

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Exclusion Criteria

• • Prisoners
• Adults unable to consent
• End stage renal disease on hemodialysis
• Indwelling urinary catheter
• Child-Pugh class C hepatic failure
• Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine
• patients known to be CYP2D6 poor metabolizers
• History of prostatectomy or cystectomy
• Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perioperative Tamsulosin Hydrochloride	Tamsulosin Hydrochloride	Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery.

Primary Outcome Measures

Name	Time	Method
Participants With Post-Operative Urinary Retention (Pour)	5 days	Proportion of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery as compared to historic controls.

Trial Locations

Locations (1)

UMass Memorial Healthcare, Inc.; 🇺🇸 Worcester, Massachusetts, United States