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

Urinary Retention Clinical Trial

— POUR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994431
• Other study ID #: H00018178
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: Feiran Lou, MD
• Phone: 509-334-8996
• Email: feiran.lou[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Diseases
• Urinary Retention

Intervention

Drug:
• Tamsulosin Hydrochloride
0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.

Locations

Country	Name	City	State
United States	UMass Memorial Healthcare, Inc.	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Feiran Lou	UMass Memorial Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with Post-Operative Urinary Retention (Pour)	Percentage of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery	5 days