Urinary RetentionPhase 2TEMPOURNCT03314025
Prophylactic Tamsulosin in Prevention of Post-operative Urinary Retention in Men After Transanal Endoscopic Microsurgery
A Phase 2 study testing Tamsulosin Hydrochloride 0.4 MG and Foley catheter in people with Urinary Retention, run by CHU de Quebec-Universite Laval at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Tamsulosin Hydrochloride 0.4 MG and Foley catheter
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Oct 2017to 1 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients of 18 years and older that are scheduled for a TEM resection during the study period.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 1 recruiting
- Withdrawn
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
- Recruiting
CHU de Quebec - Universite Laval
Québec, Quebec, G1L 3L5
Sebastien Drolet, MD, FRCSC, (418)525-4444 ext. 54160, Sebastien.Drolet.chx@gmail.com
Ann Wright, RN, (418)525-4444 ext. 53887, Ann.Wright@chuq.qc.ca
- Terminated
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
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
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.
Read the detailed description
We are conducting a feasibility study (Vanguard phase) with three Canadian centers :
- CHU de Quebec - Laval University, Quebec City, Quebec, Canada
- St-Paul's Hospital, Vancouver, British-Columbia, Canada
- 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
- Urinary Retention
- Being tested
- Tamsulosin Hydrochloride 0.4 MG, Placebo oral capsule, Foley catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin Hydrochloride 0.4 MGDrug
Also called Tamsulosin
Peri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days.
Placebo oral capsuleDrug
Also called Sugar pill, Control
Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.
Foley catheterDevice
Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | 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 Receives: Drug: Tamsulosin Hydrochloride 0.4 MG; Device: Foley catheter |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo oral capsule; Device: Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (6)
Side effects of Tamsulosin Hydrochloride
Every potential side effect will be reported
Measured: 7 days
Hospital admission
Every admission related to the primary outcome
Measured: 24 hours
Indwelling catheter
Duration of the indwelling catheter (24-48 hours vs more than 48 hours)
Measured: 1 month
Recurrence
Recurrence of urinary retention after catheter removal
Measured: 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
Measured: 7 days
Late POUR
Late post-operative urinary retention
Measured: Between 6 hours and 24 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start6 Oct 2017
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Drolet, MD FRCSC, Principal investigator, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314025
- Sponsor's protocol ID
- 2015-2392
- Acronym
- TEMPOUR
- Status last verified
- May 2021
- First submitted
- 15 Oct 2017
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27286124Bailey HR, Ferguson JA. Prevention of urinary retention by fluid restriction following anorectal operations. Dis Colon Rectum. 1976 Apr;19(3):250-2. doi: 10.1007/BF02590913.
PubMed 1269351Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.
PubMed 19352147Barkin J, Diles D, Franks B, Berner T. Alpha blocker monotherapy versus combination therapy with antimuscarinics in men with persistent LUTS refractory to alpha-adrenergic treatment: patterns of persistence. Can J Urol. 2015 Aug;22(4):7914-23.
PubMed 26267031Bozlu M, Ulusoy E, Doruk E, Cayan S, Canpolat B, Schellhammer PF, Akbay E. Voiding impairment after prostate biopsy: does tamsulosin treatment before biopsy decrease this morbidity? Urology. 2003 Dec;62(6):1050-3. doi: 10.1016/j.urology.2003.07.006.
PubMed 14665353Buckley BS, Lapitan MC. Drugs for treatment of urinary retention after surgery in adults. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD008023. doi: 10.1002/14651858.CD008023.pub2.
PubMed 20927768Cataldo PA, Senagore AJ. Does alpha sympathetic blockade prevent urinary retention following anorectal surgery? Dis Colon Rectum. 1991 Dec;34(12):1113-6. doi: 10.1007/BF02050073.
PubMed 1959461Chung SJ, Jung SI, Ryu JW, Hwang EC, Kwon DD, Park K, Kim JW. The preventive effect of tamsulosin on voiding dysfunction after prostate biopsy: a prospective, open-label, observational study. Int Urol Nephrol. 2015 May;47(5):711-5. doi: 10.1007/s11255-015-0955-7. Epub 2015 Mar 27.
PubMed 25812823Dreijer B, Moller MH, Bartholdy J. Post-operative urinary retention in a general surgical population. Eur J Anaesthesiol. 2011 Mar;28(3):190-4. doi: 10.1097/EJA.0b013e328341ac3b.
PubMed 21206278Elshaikh MA, Ulchaker JC, Reddy CA, Angermeier KW, Klein EA, Chehade N, Altman A, Ciezki JP. Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final report of a double-blind placebo-controlled randomized study. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):164-9. doi: 10.1016/j.ijrobp.2004.09.036.
PubMed 15850917Fisher E, Subramonian K, Omar MI. The role of alpha blockers prior to removal of urethral catheter for acute urinary retention in men. Cochrane Database Syst Rev. 2014 Jun 10;2014(6):CD006744. doi: 10.1002/14651858.CD006744.pub3.
PubMed 24913721Goldman G, Leviav A, Mazor A, Kashtan H, Aladgem D, Greenstein A, Wiznitzer T. Alpha-adrenergic blocker for posthernioplasty urinary retention. Prevention and treatment. Arch Surg. 1988 Jan;123(1):35-6. doi: 10.1001/archsurg.1988.01400250037005.
PubMed 3337653Gonullu NN, Dulger M, Utkan NZ, Canturk NZ, Alponat A. Prevention of postherniorrhaphy urinary retention with prazosin. Am Surg. 1999 Jan;65(1):55-8.
PubMed 9915533Jang JH, Kang SB, Lee SM, Park JS, Kim DW, Ahn S. Randomized controlled trial of tamsulosin for prevention of acute voiding difficulty after rectal cancer surgery. World J Surg. 2012 Nov;36(11):2730-7. doi: 10.1007/s00268-012-1712-z.
PubMed 22806208Jeong IG, You D, Yoon JH, Hong S, Lim JH, Hong JH, Choo MS, Ahn H, Kim CS. Impact of tamsulosin on urinary retention following early catheter removal after robot-assisted laparoscopic radical prostatectomy: a prospective randomized controlled trial. Int J Urol. 2014 Feb;21(2):164-8. doi: 10.1111/iju.12225. Epub 2013 Jul 30.
PubMed 23906190
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03314025
- Acronym / sponsor ID
- TEMPOUR / 2015-2392
- Conditions
- Urinary Retention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We are conducting a feasibility study (Vanguard phase) with three Canadian centers :
- CHU de Quebec - Laval University, Quebec City, Quebec, Canada
- St-Paul's Hospital, Vancouver, British-Columbia, Canada
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: Tamsulosin Hydrochloride 0.4 MG, Device: Foley catheterThe 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 |
| Placebo | Placebo comparator | Drug: Placebo oral capsule, Device: Foley catheterThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients of 18 years and older that are scheduled for a TEM resection during the study period.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosin Hydrochloride 0.4 MGAlso: TamsulosinPeri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days. | Drug | Tamsulosin |
| Placebo oral capsuleAlso: Sugar pill, ControlPeri-operative therapy of a Placebo oral capsule daily for a total of 7 days. | Drug | Placebo |
| Foley catheterEvery patient with a post-operative urinary retention will have a foley catheter, as standard of care. | Device | Placebo, Tamsulosin |
Primary outcome
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 secondary outcomes
Side effects of Tamsulosin Hydrochloride
Time frame: 7 days
Hospital admission
Time frame: 24 hours
Indwelling catheter
Time frame: 1 month
Recurrence
Time frame: 24 hours after the removal of the catheter
The International Prostate Symptom Score (IPSS) Score
Time frame: 7 days
Late POUR
Time frame: Between 6 hours and 24 hours post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Background: PubMed 27286124Akkoc 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.
- Background: PubMed 1269351Bailey HR, Ferguson JA. Prevention of urinary retention by fluid restriction following anorectal operations. Dis Colon Rectum. 1976 Apr;19(3):250-2. doi: 10.1007/BF02590913.
- Background: PubMed 19352147Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.
- Background: PubMed 26267031Barkin J, Diles D, Franks B, Berner T. Alpha blocker monotherapy versus combination therapy with antimuscarinics in men with persistent LUTS refractory to alpha-adrenergic treatment: patterns of persistence. Can J Urol. 2015 Aug;22(4):7914-23.
- Background: PubMed 14665353Bozlu M, Ulusoy E, Doruk E, Cayan S, Canpolat B, Schellhammer PF, Akbay E. Voiding impairment after prostate biopsy: does tamsulosin treatment before biopsy decrease this morbidity? Urology. 2003 Dec;62(6):1050-3. doi: 10.1016/j.urology.2003.07.006.
- Background: PubMed 20927768Buckley BS, Lapitan MC. Drugs for treatment of urinary retention after surgery in adults. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD008023. doi: 10.1002/14651858.CD008023.pub2.
- Background: PubMed 1959461Cataldo PA, Senagore AJ. Does alpha sympathetic blockade prevent urinary retention following anorectal surgery? Dis Colon Rectum. 1991 Dec;34(12):1113-6. doi: 10.1007/BF02050073.
- Background: PubMed 25812823Chung SJ, Jung SI, Ryu JW, Hwang EC, Kwon DD, Park K, Kim JW. The preventive effect of tamsulosin on voiding dysfunction after prostate biopsy: a prospective, open-label, observational study. Int Urol Nephrol. 2015 May;47(5):711-5. doi: 10.1007/s11255-015-0955-7. Epub 2015 Mar 27.
- Background: PubMed 21206278Dreijer B, Moller MH, Bartholdy J. Post-operative urinary retention in a general surgical population. Eur J Anaesthesiol. 2011 Mar;28(3):190-4. doi: 10.1097/EJA.0b013e328341ac3b.
- Background: PubMed 15850917Elshaikh MA, Ulchaker JC, Reddy CA, Angermeier KW, Klein EA, Chehade N, Altman A, Ciezki JP. Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final report of a double-blind placebo-controlled randomized study. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):164-9. doi: 10.1016/j.ijrobp.2004.09.036.
- Background: PubMed 24913721Fisher E, Subramonian K, Omar MI. The role of alpha blockers prior to removal of urethral catheter for acute urinary retention in men. Cochrane Database Syst Rev. 2014 Jun 10;2014(6):CD006744. doi: 10.1002/14651858.CD006744.pub3.
- Background: PubMed 3337653Goldman G, Leviav A, Mazor A, Kashtan H, Aladgem D, Greenstein A, Wiznitzer T. Alpha-adrenergic blocker for posthernioplasty urinary retention. Prevention and treatment. Arch Surg. 1988 Jan;123(1):35-6. doi: 10.1001/archsurg.1988.01400250037005.
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Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien Drolet, MD FRCSC principal investigator
CHU de Quebec-Universite Laval
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamsulosin Hydrochloride 0.4 MG and Foley catheter in people with Urinary Retention, run by CHU de Quebec-Universite Laval at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudya Morin, MD ((418)641-9732, Claudya.Morin.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operative Urinary Retention (POUR) (yes or no) (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314025, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.