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

NCT ID: NCT04994431

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-10-04

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.

Conditions

Thoracic Diseases; Urinary Retention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Perioperative 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.

Group Type: EXPERIMENTAL

Tamsulosin Hydrochloride

Intervention Type: DRUG

0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.

Historical Comparator

Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tamsulosin Hydrochloride

0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

UMass Memorial Health

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feiran Lou, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

UMass Memorial Healthcare, Inc.

Worcester, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H00018178

Identifier Type: -

Identifier Source: org_study_id