RECRUITING Phase 3 ClinicalTrials.gov

Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection

Sponsor: CHU de Quebec-Universite Laval • ClinicalTrials.gov ID: NCT05941806

Registry updated: 2026-09-10

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Description

The study will be a phase III double-blind randomized clinical trial. Participants will be recruited from the Department of General Surgery of the CHU de Québec - Saint-François-d'Assise and Hôtel-Dieu de Québec. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication.The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.

Interventions

pr Sandoz Tamsulosin (Drug)
Sandoz Tamsulosin, the study drug, is an alpha1-adrenergic blocking agent approved by Health Canada for men with bladder outlet obstruction symptoms associated with benign prostatic hyperplasia.
Glucose (Drug)
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

Eligibility criteria

Inclusion Criteria: * Male patients * 18 years and older * Scheduled for rectal resection during the study period. Exclusion Criteria: * Patients undergoing revisional surgery * Patients taking alpha-blocker medication, * Patients who have an indwelling urinary catheter, * Patients who have undergone urinary tract surgery, * Patients who will have an intraoperative trauma of the urinary tract, * Patients who will keep their urinary catheter for more than 24 hours after surgery, * Patients who have an intolerance to alpha-blocking drugs or who take one of the following drugs (potential interaction): anti-retroviral, antifungal, clarithromycin, erythromycin, paroxetine, terbinafine, cimetidine, coumadin or phosphodiesterase inhibitors. * Patients who will have an epidural anesthesia

Conditions

Urinary Retention Colorectal Surgery Rectal Resection Post-operative Urinary Retention Tamsulosin

Locations

Hôpital Saint-François d'Assise — Québec, Quebec, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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