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Alpha-1 Adrenergic Receptor Antagonist

Tamsulosin for Post-Operative Urinary Retention (POUR Trial)

Phase 4

Recruiting

Led By Feiran Lou, MD

Research Sponsored by Feiran Lou

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 days

Awards & highlights

POUR Trial Summary

This trial is testing if a common medication used to treat urinary issues can help reduce the rates of post-operative urinary retention in people who are at high risk for this complication after surgery.

Who is the study for?

This trial is for male patients aged 60 or older who are undergoing inpatient thoracic surgery. They must not have severe liver failure, be on certain medications like strong CYP inhibitors, have a history of prostatectomy, end-stage kidney disease, known allergies to tamsulosin or sulfonamides, glaucoma, low blood pressure, or plans for cataract surgery soon.Check my eligibility

What is being tested?

The study is testing if taking tamsulosin before thoracic surgery can prevent urinary retention after the operation. It's a forward-looking study where high-risk patients receive this medication as a preventative measure.See study design

What are the potential side effects?

Tamsulosin may cause dizziness due to low blood pressure upon standing up (orthostatic hypotension), headaches, issues with ejaculation and rarely may affect eye surgery outcomes.

POUR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man over 60 planning to have major chest surgery as an inpatient.

POUR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participants with Post-Operative Urinary Retention (Pour)

Side effects data

From 2018 Phase 4 trial • 715 Patients • NCT02757768

Headache

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Mirabegron

Placebo

POUR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Perioperative Tamsulosin HydrochlorideExperimental Treatment1 Intervention

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 II: Historical ComparatorActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamsulosin Hydrochloride

2018

Completed Phase 4

~1240

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Feiran LouLead Sponsor

UMass Memorial Health CareUNKNOWN

1 Previous Clinical Trials

109 Total Patients Enrolled

Feiran Lou, MDPrincipal InvestigatorUMass Medical School

Media Library

Urinary Retention Research Study Groups: Historical Comparator, Perioperative Tamsulosin Hydrochloride

Urinary Retention Clinical Trial 2023: Tamsulosin Hydrochloride Highlights & Side Effects. Trial Name: NCT04994431 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Tamsulosin Hydrochloride received regulatory authorization from the FDA?

"Tamsulosin Hydrochloride has already been approved and the safety rating is therefore a 3."

Answered by AI

For what medical purposes is Tamsulosin Hydrochloride typically utilized?

"Tamsulosin Hydrochloride can provide relief from bladder outlet obstruction, ureteral calculus, and benign prostatic hyperplasia (BPH)."

Answered by AI

Are there currently opportunities for participation in this research project?

"Right, the records available from clinicaltrials.gov verify that this research trial is currently enrolling volunteers. This medical experiment was initially listed on August 1st 2021 and last revised on February 10th 2022; 60 participants are being sought at one location."

Answered by AI

Are there any records of prior experiments involving Tamsulosin Hydrochloride?

"Currently, 13 clinical trials are underway for Tamsulosin Hydrochloride with 3 of them at the penultimate stage. Most sites are located in Baden, Aargau; however, there is a total of thirteen places where research involving this medication is taking place."

Answered by AI

What is the aggregate amount of people taking part in this trial?

"Confirmed. Clinicaltrials.gov data verifies that this trial, which was initially posted on August 1st 2021, is currently searching for 60 patients from a single medical site. The information was last updated on February 10th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Feiran Lou 2021. "Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04994431.

All > Urinary Retention