Your session is about to expire
← Back to Search
Prophylactic Tamsulosin for Urinary Retention After Colorectal Surgery (R-POUR Trial)
Phase 3
Waitlist Available
Led By Frédérique Beauchamp, MD
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
Scheduled for rectal resection during the study period.
Male patients 18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during hospital stay: up to two weeks
Awards & highlights
R-POUR Trial Summary
This trial will test if tamsulosin can reduce post-op urinary retention in men after rectal surgery. Secondary outcomes are length of stay, number of catheterizations, re-insertions, & duration of catheter.
Who is the study for?
This trial is for male patients aged 18 or older who are scheduled for rectal resection. It's not open to those with urinary tract trauma, epidural anesthesia during surgery, revisional surgeries, past urinary tract surgeries, current alpha-blocker medication use, indwelling catheters post-surgery over 24 hours, or intolerance to alpha-blockers.Check my eligibility
What is being tested?
The study tests if Tamsulosin can prevent urinary retention after rectum resection in men. It's a phase III trial where participants are randomly given either Tamsulosin or a placebo without knowing which one they receive (double-blind). Hospital stay length and number of catheterizations will also be compared.See study design
What are the potential side effects?
Tamsulosin may cause dizziness, headache, sleepiness, nausea, low blood pressure upon standing up (orthostatic hypotension), and ejaculation problems. These side effects aren't guaranteed but are possible.
R-POUR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery to remove part of my rectum.
Select...
I am a man aged 18 or older.
R-POUR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the length of hospital stay: up to two weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the length of hospital stay: up to two weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative urinary retention
Secondary outcome measures
Length of stay
Number of urinary catheterizations
Number of urine catheter reinsertions
+1 moreR-POUR Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Group receiving TamsulosinActive Control1 Intervention
Patients randomized to the intervention group will receive 0.4 mg tamsulosin capsules, administered orally, once a day for 5 days before surgery, the morning of surgery and the day after surgery. The steady-state plasma concentration of tamsulosin is reached after 4 to 5 consecutive doses, which justify the administration duration of 5 days preoperatively. The total duration of administration of tamsulosin was established at 7 days since the study of Patel et al. showed a significant reduction in POUR after 7 days of administration.
Group II: Group receiving PlaceboPlacebo Group1 Intervention
Patients assigned to the placebo group will receive glucose capsules according to the same protocol. The glucose capsules will be manufactured by the pharmacy of the CHU de Quebec.
Find a Location
Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
106,937 Total Patients Enrolled
1 Trials studying Urinary Retention
158 Patients Enrolled for Urinary Retention
Fédération des médecins résidents du QuébecUNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
Frédérique Beauchamp, MDPrincipal Investigator
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery to remove part of my rectum.You are not expected to have a urinary catheter for more than 24 hours after surgery.You have a tube in your bladder to help you pee.I will have surgery that involves my urinary system.I will receive epidural anesthesia.I am scheduled for a corrective surgery.I have had surgery on my urinary system.I am a man aged 18 or older.I am currently taking medication for high blood pressure or prostate issues.I cannot tolerate alpha-blockers or I am taking medication that could interact with the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Group receiving Placebo
- Group 2: Group receiving Tamsulosin
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an open enrollment period for this experiment?
"As indicated on clinicaltrials.gov, the recruitment for this medical trial has concluded as of July 4th 2023. This research was initially posted in August 1st 2023 and no longer accepts applicants; however, 53 other studies listed are still actively enrolling participants."
Answered by AI
What safety protocols are in place for participants receiving tamsulosin?
"Our analysts assigned a safety score of 3 to the group receiving tamsulosin due to existing clinical data indicating efficacy and multiple rounds confirming its security."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger