A Phase 2 interventional study of Tamsulosin Hydrochloride 0.4 MG and Placebo oral capsule in Urinary Retention, sponsored by CHU de Quebec-Universite Laval. Status unknown at 3 sites in Canada. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-19.
Sponsored by CHU de Quebec-Universite Laval · Phase 2, Interventional, and Prevention
Among 26 studies testing tamsulosin in Urinary Retention — 7 open to participants now, 7 under way, 2 of them phase 3. Tamsulosin · Urinary Retention.
Among the 26 studies testing tamsulosin in Urinary Retention, this one is the 10th largest by planned enrollment, is one of 5 that started in 2017, is one of 4 in phase 2, and was the 11th registered.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's planned enrollment of 158 is above the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →7 of the 26 studies testing tamsulosin in Urinary Retention are open now, in 3 countries. Each count lists the studies.
Tamsulosin: first FDA approval 1997 (FLOMAX). What it is approved for, and how studies give it, is on its page →
Of the 31 Urinary Retention studies recruiting now, 23 (74%) set no upper age limit and 5 (16%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · male · healthy volunteers too.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 5 started in 2017.
Median enrollment 136 across the 26 interventional studies. Of the 16 that completed or were terminated, 9 (56%) have results posted.
1 of 26 have an industry lead sponsor. The 10 most frequent:
CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.
CHU de Quebec-Universite Laval has 2 studies filed under Urinary Retention — fewer than ten, so there is no comparison to draw.
4 of the studies testing tamsulosin in Urinary Retention that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05941806Phase 3CHU de Quebec-Universite LavalProphylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection | 2027-07-30 |
| NCT04597372Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery | 2026-12 |
| NCT07174349Mayo ClinicUroselective Alpha-1-Antagonist to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery | 2027-01-31 |
| NCT05657990Hackensack Meridian HealthPost Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery | 2027-06 |
Among the 26 studies testing tamsulosin in Urinary Retention, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
We are conducting a feasibility study (Vanguard phase) with three Canadian centers :
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Anti-retroviral therapy, Antifungal drug, Clarithromycin, Erythromycin, Paroxetine, Terbinafine, Cimetidine, Warfarin, Sildenafil, Tadalafil, Vardenafil (these drugs have possible interactions with the study drug)
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
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
Peri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days.
Also known as: Tamsulosin
Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.
Also known as: Sugar pill, Control
Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.
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.
Time frame: 6 hours
Side effects of Tamsulosin Hydrochloride
Every potential side effect will be reported
Time frame: 7 days
Hospital admission
Every admission related to the primary outcome
Time frame: 24 hours
Indwelling catheter
Duration of the indwelling catheter (24-48 hours vs more than 48 hours)
Time frame: 1 month
Recurrence
Recurrence of urinary retention after catheter removal
Time frame: 24 hours after the removal of the catheter
The International Prostate Symptom Score (IPSS) Score
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
Time frame: 7 days
Late POUR
Late post-operative urinary retention
Time frame: Between 6 hours and 24 hours post-op
Started Oct 2017 (actual). Primary completion is estimated for Oct 2022, 59 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tamsulosin
CHU de Quebec-Universite Laval →