Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery
NCT ID: NCT03314025
Last Updated: 2021-05-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
158 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-06
Study Completion Date
2022-10-01
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Urinary Retention
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized, double-blind, placebo-controlled clinical trial
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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.
Study Groups
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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
Group Type
EXPERIMENTAL
Tamsulosin Hydrochloride 0.4 MG
Intervention Type
DRUG
Peri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days.
Foley catheter
Intervention Type
DEVICE
Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.
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
Group Type
PLACEBO_COMPARATOR
Placebo oral capsule
Intervention Type
DRUG
Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.
Foley catheter
Intervention Type
DEVICE
Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.
Interventions
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Tamsulosin Hydrochloride 0.4 MG
Peri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days.
Intervention Type
DRUG
Placebo oral capsule
Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.
Intervention Type
DRUG
Foley catheter
Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.
Intervention Type
DEVICE
Other Intervention Names
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Tamsulosin
Sugar pill
Control
Eligibility Criteria
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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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sebastien Drolet, MD FRCSC
Role: PRINCIPAL_INVESTIGATOR
CHU de Quebec-Universite Laval
Locations
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St. Paul's Hospital
Vancouver, British Columbia, Canada
Site Status
TERMINATED
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Site Status
WITHDRAWN
CHU de Quebec - Universite Laval
Québec, Quebec, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Akkoc A, Aydin C, Topaktas R, Kartalmis M, Altin S, Isen K, Metin A. Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. Int Braz J Urol. 2016 May-Jun;42(3):578-84. doi: 10.1590/S1677-5538.IBJU.2015.0256.
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Couture T, Morin C, Charbonneau J, Papillon-Dion E, Bouchard A, Rouleau-Fournier F, Bouchard P, Letarte F, Turgeon AF, Drolet S. TEMPOUR: A Randomized Controlled Trial Assessing Perioperative Use of an Alpha-1 Blocker to Reduce Postoperative Urinary Retention After Transanal Endoscopic Microsurgery Procedures. Dis Colon Rectum. 2025 Apr 1;68(4):475-482. doi: 10.1097/DCR.0000000000003623. Epub 2025 Jan 2.
Reference Type
DERIVED
Other Identifiers
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2015-2392
Identifier Type: -
Identifier Source: org_study_id
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PHASE3
Uroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery
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RECRUITING
PHASE4
Efficacy and Safety of Tadalafil, Tamsulosin, and Their Combinations in Treating Lower Urinary Tract Symptoms in BPH Patients with Prostate Volumes ≤ 40 Ml: a Prospective Comparative Study
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COMPLETED
PHASE4
Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.
NCT06737016
RECRUITING
PHASE3
Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
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COMPLETED
PHASE2
Deprescribing Tamsulosin in Older Men
NCT05415748
COMPLETED
PHASE4
Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia
NCT02827578
UNKNOWN
PHASE3
A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
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COMPLETED
PHASE4
Efficacy Study of Tamsulosin and Tolterodine Treatment for Chronic Prostatitis
NCT00913315
UNKNOWN
NA
Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer
NCT00244309
COMPLETED
PHASE3
An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
NCT01726270
COMPLETED
PHASE2