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

May 17, 2021 updated by: CHU de Quebec-Universite Laval

Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

We are conducting a feasibility study (Vanguard phase) with three Canadian centers :

  1. CHU de Quebec - Laval University, Quebec City, Quebec, Canada
  2. St-Paul's Hospital, Vancouver, British-Columbia, Canada
  3. Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Other Canadian centers will be offered to join our study if the Vanguard phase demonstrates the feasibility of this clinical trial.

Large scale study

We anticipate the detection of a 15% absolute risk reduction of POUR in the Experimental group in comparison with the Placebo group. To detect a 15% reduction of POUR in the Experimental group (10% anticipated) in comparison with the Placebo group (25% anticipated) and to assure a study power of 80% with a unilateral Chi2 and a significance level of 5%, we need 158 patients in total; 79 in each group.

Feasibility study (Vanguard phase)

We expect at least a 60% recruitment rate throughout the two first participating Canadian centers, which translates into a mean of 8 patients recruited each month overall. Regarding the medication adherence, two studies that evaluated the use patterns and adherence to medications for lower urinary tract symptoms suggestive of benign prostatic hyperplasia found an adherence of 67% to 89%, with a mean of 78%. Based on these two studies, we expect that the patients will at least take 80% of the medication at study. To detect an 80% medication adherence with a 95% confidence interval, we need 62 enrolled patients.

The research pharmacy at the CHU de Quebec - Laval University will be responsible for preparing the study drug. The active medication or the placebo (sugar) will be encapsulated using identical capsules. The research pharmacy at the coordinating center will provide the study drug and the placebo to the other participating centers. There will be a quality control of the capsules; a temperature monitor will be in the boxes sent to the other centers and a control on the expiration date will be made. The capsules that are not used will be destroyed at each center. The randomization will be kept at the CHU de Quebec - Laval University research center. Patients will be stratified by center.

The patients are asked to report any potential adverse effect and our data safety monitoring board will meet annually to assess these or sooner if any adverse effect is serious.

We justify the duration of the intervention by the time needed to reach a steady state, which is estimated to be 4 to 5 days. The 7-day therapy is also based on the study from Patel et al, which showed a significant reduction of acute urinary retention with a 7-day intake of tamsulosin. It is the common and recommended dose used in other patient population.

Data collection

Patients will be identified by a study number in the study database. A master list of participants linking their study number with their medical record number will be kept in the computer of the PI at every research center participating in the study, and will be password protected. Data will be collected prospectively at the bedside during the study period.

Statistical analysis

First, a descriptive analysis of the population at study will be performed for socio- demographic, anthropometric and clinical characteristics. The means, standard deviations, medians and interquartile ranges will be presented as continuous numerical variables, while the frequencies and percentages will be determined for categorical variables. In the large-scale study, a Chi-square test or Fisher Exact test, if appropriate, will be used for the analysis of the primary endpoint, which is the comparison of the rate of POUR in the Experimental group with the rate of POUR in the Placebo group. This same test will also be helpful in the analysis of the secondary endpoints. If the patient doesn't take all of his medication or his surgery is cancelled he will still be included, since this will be an intention-to-treat analysis. Sub-group analyses will be performed to evaluate the impact of the tumour's characteristics, the duration of the surgery, the volume of intravenous fluids received during the intervention, the type of anaesthesia and the International Prostate Symptom Score (IPSS).

Potential conflicts of interest

This is an investigator-led study that is independent and not sponsored by the industry. The study is funded through local funds (CHU de Quebec - Laval University, Department of Surgery) as well as from in-kind funding of the institution.

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Terminated
        • St. Paul's Hospital
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Withdrawn
        • Ottawa Hospital Research Institute
    • Quebec
      • Quebec City, Quebec, Canada, G1L 3L5
        • Recruiting
        • CHU de Québec - Université Laval
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastien Drolet, MD FRCSC
        • Sub-Investigator:
          • Claudya Morin, MD
        • Sub-Investigator:
          • Alexandre Bouchard, MD FRCSC
        • Sub-Investigator:
          • Philippe Bouchard, MD FRCSC
        • Sub-Investigator:
          • Alexis Turgeon-Fournier, MD MSc FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Tamsulosin Hydrochloride 0.4 MG
Peri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days.
Other Names:
  • Tamsulosin
Device: Foley catheter
Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.
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
Device: Foley catheter
Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.
Drug: Placebo oral capsule
Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.
Other Names:
  • Control
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Operative Urinary Retention (POUR) (yes or no)
Time Frame: 6 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects of Tamsulosin Hydrochloride
Time Frame: 7 days
Every potential side effect will be reported
7 days
Hospital admission
Time Frame: 24 hours
Every admission related to the primary outcome
24 hours
Indwelling catheter
Time Frame: 1 month
Duration of the indwelling catheter (24-48 hours vs more than 48 hours)
1 month
Recurrence
Time Frame: 24 hours after the removal of the catheter
Recurrence of urinary retention after catheter removal
24 hours after the removal of the catheter
The International Prostate Symptom Score (IPSS) Score
Time Frame: 7 days

The standardized questionnaire will be submitted to the patients before and after the prophylactic therapy. The score is out of 35.

Score Correlation

0-7 Mildly symptomatic

8-19 Moderately symptomatic

20-35 Severely symptomatic
7 days
Late POUR
Time Frame: Between 6 hours and 24 hours post-op
Late post-operative urinary retention
Between 6 hours and 24 hours post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Investigators

  • Principal Investigator: Sebastien Drolet, MD FRCSC, CHU de Quebec-Universite Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 6, 2017

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

October 15, 2017

First Submitted That Met QC Criteria

October 15, 2017

First Posted (ACTUAL)

October 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-2392

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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