Recruiting
Phase 3

Tamsulosin

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT05941806

Conditions

Urinary Retention

Colorectal Surgery

Rectal Resection

Post-operative Urinary Retention

Tamsulosin

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

pr Sandoz Tamsulosin

Glucose

Study Details

Brief 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

Study ID

NCT05941806

Start date

Nov 10, 2023

Status verified date

Sep, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Group receiving Tamsulosin

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.

placebo comparator: Group receiving Placebo

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.

Interventions

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.

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

Primary outcome measure

  • Postoperative urinary retention [ Time Frame: During the length of hospital stay: up to two weeks ]

Central Contacts and Locations

Central contacts

Frédérique Beauchamp, MD

4182717881frederique.beauchamp.1@ulaval.ca

Sébastien Drolet, MD FRCSC

4184550900sebastien.drolet.chx@gmail.com

Locations

Hôpital Saint-François d'Assise

Recruiting

Québec, Quebec, Canada, G1L 3L5

Contacts

Beauchamp Frédérique, MD

4182717881frederique.beauchamp.1@ulaval.ca

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-09-10.