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

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ClinicalTrials.gov Identifier: NCT03314025
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

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
Urinary Retention Drug: Tamsulosin Hydrochloride 0.4 MG Drug: Placebo oral capsule Device: Foley catheter Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 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 : October 6, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Side effects of Tamsulosin Hydrochloride [ Time Frame: 7 days ]
    Every potential side effect will be reported

  2. Hospital admission [ Time Frame: 24 hours ]
    Every admission related to the primary outcome

  3. Indwelling catheter [ Time Frame: 1 month ]
    Duration of the indwelling catheter (24-48 hours vs more than 48 hours)

  4. Recurrence [ Time Frame: 24 hours after the removal of the catheter ]
    Recurrence of urinary retention after catheter removal

  5. 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


  6. Late POUR [ Time Frame: Between 6 hours and 24 hours post-op ]
    Late post-operative urinary retention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314025


Contacts
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Contact: Claudya Morin, MD (418)641-9732 Claudya.Morin.1@ulaval.ca
Contact: Ann Wright, RN (418)525-4444 ext 53887 Ann.Wright@chuq.qc.ca

Locations
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Canada, British Columbia
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Rohan Kakkar    (604) 682-2344 ext 66040    rkakkar@providencehealth.bc.ca   
Principal Investigator: Carl Brown, MD FRCSC         
Canada, Ontario
Ottawa Hospital Research Institute Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Nancy Laffin, RN BScN    613-798-5555 ext 18422    nlaffin@toh.ca   
Principal Investigator: Reilly Musselman, MD FRCSC         
Sub-Investigator: Lara Williams, MD FRCSC         
Canada, Quebec
CHU de Quebec - Universite Laval Recruiting
Quebec City, Quebec, Canada, G1L 3L5
Contact: Sebastien Drolet, MD, FRCSC    (418)525-4444 ext 54160    Sebastien.Drolet.chx@gmail.com   
Contact: Ann Wright, RN    (418)525-4444 ext 53887    Ann.Wright@chuq.qc.ca   
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         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: Sebastien Drolet, MD FRCSC CHU de Quebec-Universite Laval

Publications:

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Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03314025    
Other Study ID Numbers: 2015-2392
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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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:
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Urinary Retention
Urination Disorders
Urologic Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents