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

Sponsor

Feiran Lou (Other)

Overall Status

Recruiting

CT.gov ID

NCT04994431

Collaborator

UMass Memorial Health Care (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Diseases Urinary Retention	Drug: Tamsulosin Hydrochloride	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

All subjects that sign a study consent and meet inclusion and exclusion criteria will receive the the study drug.All subjects that sign a study consent and meet inclusion and exclusion criteria will receive the the study drug.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Tamsulosin Hydrochloride 0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Tamsulosin Hydrochloride

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

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Participants with Post-Operative Urinary Retention (Pour) [5 days]
Percentage of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMass Memorial Healthcare, Inc.	Worcester	Massachusetts	United States	01655

Sponsors and Collaborators

Feiran Lou
UMass Memorial Health Care

Investigators

Principal Investigator: Feiran Lou, MD, UMass Medical School

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Feb 24, 2021

More Information

Publications

None provided.

Responsible Party:

Feiran Lou, Assistant Professor, University of Massachusetts, Worcester

ClinicalTrials.gov Identifier:

NCT04994431

Other Study ID Numbers:

H00018178

First Posted:

Aug 6, 2021

Last Update Posted:

Feb 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Thoracic Diseases

Urinary Retention

Tamsulosin

Study Results

No Results Posted as of Feb 11, 2022