Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery

NCT03314025 | Unknown Phase 2 DMC

• 1 other identifier: 2015-2392
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Post-Operative Urinary Retention (POUR) (yes or no)

  The absence of natural voiding after a surgery needing an intervention as a Foley catheter or a catheterization. If the patient needs this intervention, he will be stated to have had a POUR.

  6 hours

Secondary Outcomes (6)

• Side effects of Tamsulosin Hydrochloride

  7 days

• Hospital admission

  24 hours

• Indwelling catheter

  1 month

• Recurrence

  24 hours after the removal of the catheter

• The International Prostate Symptom Score (IPSS) Score

  7 days

Study Arms (2)

Tamsulosin

EXPERIMENTAL

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

Drug: Tamsulosin Hydrochloride 0.4 MG; Device: Foley catheter

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule; Device: Foley catheter

Interventions

Tamsulosin Hydrochloride 0.4 MG DRUG

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

Also known as: Tamsulosin

Tamsulosin

Placebo oral capsule DRUG

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

Also known as: Sugar pill, Control

Placebo

Foley catheter DEVICE

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

Placebo; Tamsulosin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (3)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

TERMINATED

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

WITHDRAWN

CHU de Quebec - Universite Laval

Québec, Quebec, G1L 3L5, Canada

RECRUITING

Related Publications (41)

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MeSH Terms

Conditions

Urinary Retention

Interventions

Tamsulosin; Sugars

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Carbohydrates

Study Officials

• Sebastien Drolet, MD FRCSC

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudya Morin, MD

CONTACT

(418)641-9732; Claudya.Morin.1@ulaval.ca

Ann Wright, RN

CONTACT

(418)525-4444; Ann.Wright@chuq.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Everyone is blinded except the pharmacy department where the randomization list is kept. This department is the one able to unblind a patient, if needed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 19, 2017
• Study Start: October 6, 2017
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

CA (3)