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Alpha-1 Blocker
Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery (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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
172 Previous Clinical Trials
109,517 Total Patients Enrolled
1 Trials studying Urinary Retention
220 Patients Enrolled for Urinary Retention
Sebastien Drolet, MD FRCSCPrincipal InvestigatorCHU de Quebec-Universite Laval