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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

Must not have

Patients who will have an intraoperative trauma of the urinary tract

Patients who will have an epidural anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during hospital stay: up to two weeks

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for surgery to remove part of my rectum.

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I am a man aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will have surgery that involves my urinary system.

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I will receive epidural anesthesia.

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I am scheduled for a corrective surgery.

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I have had surgery on my urinary system.

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I am currently taking medication for high blood pressure or prostate issues.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the length of hospital stay: up to two weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Postoperative urinary retention

Secondary study objectives

Length of stay

Number of urinary catheterizations

Number of urine catheter reinsertions

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 7Eligibility criteria met