Clincosm LogoSign in Get a demo

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

Sponsor
CHU de Quebec-Universite Laval (Other)
Overall Status
Recruiting
CT.gov ID
NCT03314025
Collaborator
(none)
158
Enrollment
3
Locations
2
Arms
59.8
Anticipated Duration (Months)
52.7
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tamsulosin Hydrochloride 0.4 MG
  • Drug: Placebo oral capsule
  • Device: Foley catheter
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled clinical trialRandomized, double-blind, placebo-controlled clinical trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial
Actual Study Start Date :
Oct 6, 2017
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

    Drug: Placebo oral capsule
    Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.
    Other Names:
  • Sugar pill
  • Control

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

    Outcome Measures

    Primary Outcome Measures

    1. Post-Operative Urinary Retention (POUR) (yes or no) [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.

    Secondary Outcome Measures

    1. Side effects of Tamsulosin Hydrochloride [7 days]

      Every potential side effect will be reported

    2. Hospital admission [24 hours]

      Every admission related to the primary outcome

    3. Indwelling catheter [1 month]

      Duration of the indwelling catheter (24-48 hours vs more than 48 hours)

    4. Recurrence [24 hours after the removal of the catheter]

      Recurrence of urinary retention after catheter removal

    5. The International Prostate Symptom Score (IPSS) Score [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

    6. Late POUR [Between 6 hours and 24 hours post-op]

      Late post-operative urinary retention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Paul's Hospital Vancouver British Columbia Canada V6Z 1Y6
    2 Ottawa Hospital Research Institute Ottawa Ontario Canada K1Y 4E9
    3 CHU de Quebec - Universite Laval Quebec City Quebec Canada G1L 3L5

    Sponsors and Collaborators

    • CHU de Quebec-Universite Laval

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    CHU de Quebec-Universite Laval
    ClinicalTrials.gov Identifier:
    NCT03314025
    Other Study ID Numbers:
    • 2015-2392
    First Posted:
    Oct 19, 2017
    Last Update Posted:
    May 19, 2021
    Last Verified:
    May 1, 2021
    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
    Additional relevant MeSH terms:
    Urinary Retention
    Tamsulosin

    Study Results

    No Results Posted as of May 19, 2021