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Alpha-1 Blocker

Treatment for Urinary Retention (PrePOURTS Trial)

Phase 2

Waitlist Available

Led By Rahul Nayal

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

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

Must have

Male Sex

Age greater than or equal to 40 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-op

Awards & highlights

PrePOURTS Trial Summary

This trial aims to see if tamsulosin is better than a placebo in helping reduce urinary retention and improving outcomes in people having lung surgery.

Who is the study for?

This trial is for men aged 40 or older who have had urinary retention before, a prostate symptom score of at least 1, diabetes, and are using thoracic epidural analgesia. They can't join if they're allergic to tamsulosin, recently took alpha-blockers, have a UTI or BPH being treated, neurological bladder issues, past urological surgery or disorders like strictures or cancer.Check my eligibility

What is being tested?

The study tests whether Tamsulosin Hydrochloride can prevent urinary retention after lung surgery compared to a placebo. Participants will be randomly assigned to receive either the medication or an inactive substance.See study design

What are the potential side effects?

Tamsulosin may cause dizziness, headache, sleepiness, nausea, runny nose and ejaculation problems. It might also lead to low blood pressure when standing up which could make someone faint.

PrePOURTS Trial Eligibility Criteria

Inclusion Criteria

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

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I am male.

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I am 40 years old or older.

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I have been diagnosed with diabetes.

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I have had radiation therapy to my pelvic area before.

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I am using a thoracic epidural for pain management.

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I have had issues with not being able to empty my bladder fully in the past.

PrePOURTS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-op for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of post operative urinary retention

Secondary outcome measures

Catheter related complications

Length of stay

Rate of Indwelling Catheterizations

+3 more

Side effects data

From 2018 Phase 4 trial • 715 Patients • NCT02757768

Headache

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Mirabegron

Placebo

PrePOURTS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Tamsulosin

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamsulosin Hydrochloride

2018

Completed Phase 4

~1240

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,668 Total Patients Enrolled

Rahul NayalPrincipal InvestigatorLawson Health Research Institute

Frequently Asked Questions

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

Has this therapeutic approach received the official endorsement of the Food and Drug Administration?

"Based on the phase of this trial (Phase 2), our team at Power rates the safety of this treatment as a 2. While there is some available data supporting its safety, no evidence has been found yet to support its efficacy."

Answered by AI

Are individuals still eligible to apply for participation in this ongoing trial?

"Per clinicaltrials.gov, this particular investigation is not actively seeking participants. It was initially listed on April 1st, 2024 and last revised on February 8th, 2024. While recruitment for this specific trial is paused, there are currently 37 alternative trials welcoming new subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

Rahul Nayak 2024. "Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06262048.

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