MedTrace Logo

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

NCT05941806 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-07-12

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

pr Sandoz Tamsulosin

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.

DRUG

Glucose

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

Sponsors & Collaborators

  • Fédération des médecins résidents du Québec

    collaborator UNKNOWN

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Frédérique Beauchamp, MD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-07-30
Completion
2025-07-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05941806 on ClinicalTrials.gov