Recruiting
Phase 2

Tamsulosin

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT03314025

Conditions

Urinary Retention

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tamsulosin Hydrochloride 0.4 MG

Placebo oral capsule

Foley catheter

Study Details

Brief summary:

Post-operative urinary retention (POUR) is a frequent complication reported as ranging from 10 to 55% in the literature. In a recent retrospective study from Laliberte et al in Quebec City, we observed that 19% of the patients operated using transanal endoscopic microsurgery (TEM) had a post-operative urinary retention (POUR). Factors related to the patient, the tumor and the surgery were not observed to be associated risk factors. Tamsulosin has been shown as an effective preventive agent of POUR for certain ano-rectal and inguinal surgeries. The efficacy of this prophylactic therapy in transanal endoscopic microsurgery has not been studied yet and is unclear considering the particularities of this procedure. TEM uses a rigid proctoscope of four centimeters of diameter and creates a continuous pneumorectum (insufflation of the rectum during all the procedure). We think that these two elements, which cause local inflammation, may be part of the reason explaining the high incidence of post-operative urinary retention after TEM procedures. The objective of our multicenter clinical trial is to evaluate the effect of perioperative tamsulosin for the reduction of POUR in men, as well as the impact on the interventions and hospital admissions related to this complication.

Conditions

Urinary Retention

Study ID

NCT03314025

Start date

Oct 6, 2017

Status verified date

May, 2021

Completion date

Oct 1, 2022

Anticipated

Primary completion date

Oct 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male patients of 18 years and older that are scheduled for a TEM resection during the study period.

Exclusion Criteria:

  • Patient already taking an alpha1-adrenergic blocking agent Flomax® (Tamsulosin), Cardura® (Doxazosin), Hytrin® (Terazosine) Rapaflo® (Silodosin), Xatral® (Alfuzosin), Minipress® (Prazosin)
  • Patient having an indwelling bladder catheter
  • Allergy or hypersensibility to any alpha1-adrenergic blocking agent
  • Patient taking one of the following:

Anti-retroviral therapy, Antifungal drug, Clarithromycin, Erythromycin, Paroxetine, Terbinafine, Cimetidine, Warfarin, Sildenafil, Tadalafil, Vardenafil (these drugs have possible interactions with the study drug)

Study Design

Enrollment

158 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Tamsulosin

The patients in the Experimental group will receive Tamsulosin Hydrochloride 0.4 MG (milligrams) once a day for 5 days before the surgery, one capsule on the day of the surgery and one on the day after. The intervention will consist of a total of 7 capsules

placebo comparator: Placebo

The patients in the Placebo group will receive a placebo oral capsule (sugar) once a day for 5 days before the surgery, one capsule on the day of the surgery and one on the day after. The intervention will consist of a total of 7 capsules

Interventions

Tamsulosin Hydrochloride 0.4 MG

Peri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days.

Placebo oral capsule

Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.

Foley catheter

Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.

Primary outcome measure

  • Post-Operative Urinary Retention (POUR) (yes or no) [ Time Frame: 6 hours ]

Central Contacts and Locations

Locations

CHU de Quebec - Universite Laval

Recruiting

Quebec City, Quebec, Canada, G1L 3L5

Contacts

Principal Investigator:

Sebastien Drolet, MD FRCSC

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

May 19, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2021-05-19.