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Alpha-1 Blocker

Tamsulosin Hydrochloride 0.4 MG for Urinary Retention (TEMPOUR Trial)

Phase 2

Waitlist Available

Led By Sebastien Drolet, MD FRCSC

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

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

Must have

* Male patients of 18 years and older that are scheduled for a TEM resection during the study period.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is evaluating whether the use of tamsulosin reduces the incidence of post-operative urinary retention in men who have undergone transanal endoscopic microsurgery.

Eligible Conditions

Urinary Retention

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-Operative Urinary Retention (POUR) (yes or no)

Secondary study objectives

Hospital admission

Indwelling catheter

Late POUR

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TamsulosinExperimental Treatment2 Interventions

The patients in the Experimental group will receive Tamsulosin Hydrochloride 0.4 MG (milligrams) once a day for 5 days before the surgery, one capsule on the day of the surgery and one on the day after. The intervention will consist of a total of 7 capsules

Group II: PlaceboPlacebo Group2 Interventions

The patients in the Placebo group will receive a placebo oral capsule (sugar) once a day for 5 days before the surgery, one capsule on the day of the surgery and one on the day after. The intervention will consist of a total of 7 capsules

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamsulosin

FDA approved

Foley catheter

2017

Completed Phase 2

~990

0 / 1Eligibility criteria met