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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03314025
Other study ID # 2015-2392
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 6, 2017
Est. completion date October 1, 2022

Study information

Verified date May 2021
Source CHU de Quebec-Universite Laval
Contact Claudya Morin, MD
Phone (418)641-9732
Email Claudya.Morin.1@ulaval.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 158
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tamsulosin Hydrochloride 0.4 MG
Peri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days.
Placebo oral capsule
Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.
Device:
Foley catheter
Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.

Locations

Country Name City State
Canada Ottawa Hospital Research Institute Ottawa Ontario
Canada CHU de Quebec - Universite Laval Quebec City Quebec
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

References & Publications (40)

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Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017. — View Citation

Bozlu 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. — View Citation

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Chung 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. — View Citation

Dreijer B, Møller 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. — View Citation

Elshaikh 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. — View Citation

Fisher 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;(6):CD006744. doi: 10.1002/14651858.CD006744.pub3. Review. — View Citation

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Gönüllü NN, Dülger M, Utkan NZ, Cantürk NZ, Alponat A. Prevention of postherniorrhaphy urinary retention with prazosin. Am Surg. 1999 Jan;65(1):55-8. — View Citation

Jang 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. — View Citation

Jeong 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. — View Citation

Jordan CG. Post-Operative Urinary Retention. Ann Surg. 1933 Jul;98(1):125-37. — View Citation

Kapoor A. Benign prostatic hyperplasia (BPH) management in the primary care setting. Can J Urol. 2012 Oct;19 Suppl 1:10-7. — View Citation

Keita H, Diouf E, Tubach F, Brouwer T, Dahmani S, Mantz J, Desmonts JM. Predictive factors of early postoperative urinary retention in the postanesthesia care unit. Anesth Analg. 2005 Aug;101(2):592-6, table of contents. — View Citation

Laliberte AS, Lebrun A, Drolet S, Bouchard P, Bouchard A. Transanal endoscopic microsurgery as an outpatient procedure is feasible and safe. Surg Endosc. 2015 Dec;29(12):3454-9. doi: 10.1007/s00464-015-4158-1. Epub 2015 Mar 24. — View Citation

Lamonerie L, Marret E, Deleuze A, Lembert N, Dupont M, Bonnet F. Prevalence of postoperative bladder distension and urinary retention detected by ultrasound measurement. Br J Anaesth. 2004 Apr;92(4):544-6. Epub 2004 Feb 20. — View Citation

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Madani AH, Aval HB, Mokhtari G, Nasseh H, Esmaeili S, Shakiba M, Shakiba RS, Seyed Damavand SM. Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05. — View Citation

Mason SE, Scott AJ, Mayer E, Purkayastha S. Patient-related risk factors for urinary retention following ambulatory general surgery: a systematic review and meta-analysis. Am J Surg. 2016 Jun;211(6):1126-34. doi: 10.1016/j.amjsurg.2015.04.021. Epub 2015 Jul 17. Review. — View Citation

Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19. — View Citation

Nasu K, Moriyama N, Fukasawa R, Tsujimoto G, Tanaka T, Yano J, Kawabe K. Quantification and distribution of alpha1-adrenoceptor subtype mRNAs in human proximal urethra. Br J Pharmacol. 1998 Apr;123(7):1289-93. — View Citation

Patel R, Fiske J, Lepor H. Tamsulosin reduces the incidence of acute urinary retention following early removal of the urinary catheter after radical retropubic prostatectomy. Urology. 2003 Aug;62(2):287-91. — View Citation

Petersen MS, Collins DN, Selakovich WG, Finkbeiner AE. Postoperative urinary retention associated with total hip and total knee arthroplasties. Clin Orthop Relat Res. 1991 Aug;(269):102-8. — View Citation

Petros JG, Bradley TM. Factors influencing postoperative urinary retention in patients undergoing surgery for benign anorectal disease. Am J Surg. 1990 Apr;159(4):374-6. — View Citation

Reitz A, Haferkamp A, Kyburz T, Knapp PA, Wefer B, Schurch B. The effect of tamsulosin on the resting tone and the contractile behaviour of the female urethra: a functional urodynamic study in healthy women. Eur Urol. 2004 Aug;46(2):235-40; discussion 240. — View Citation

Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16. — View Citation

Tammela T, Kontturi M, Puranen J. Prevention of postoperative urinary retention after total hip arthroplasty in male patients. Ann Chir Gynaecol. 1987;76(3):170-2. — View Citation

Toyonaga T, Matsushima M, Sogawa N, Jiang SF, Matsumura N, Shimojima Y, Tanaka Y, Suzuki K, Masuda J, Tanaka M. Postoperative urinary retention after surgery for benign anorectal disease: potential risk factors and strategy for prevention. Int J Colorectal Dis. 2006 Oct;21(7):676-82. Epub 2006 Mar 22. — View Citation

Verhamme KM, Dieleman JP, Bleumink GS, Bosch JL, Stricker BH, Sturkenboom MC. Treatment strategies, patterns of drug use and treatment discontinuation in men with LUTS suggestive of benign prostatic hyperplasia: the Triumph project. Eur Urol. 2003 Nov;44(5):539-45. — View Citation

Wu AK, Auerbach AD, Aaronson DS. National incidence and outcomes of postoperative urinary retention in the Surgical Care Improvement Project. Am J Surg. 2012 Aug;204(2):167-71. doi: 10.1016/j.amjsurg.2011.11.012. Epub 2012 May 3. — View Citation

* Note: There are 40 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 hours
Secondary Side effects of Tamsulosin Hydrochloride Every potential side effect will be reported 7 days
Secondary Hospital admission Every admission related to the primary outcome 24 hours
Secondary Indwelling catheter Duration of the indwelling catheter (24-48 hours vs more than 48 hours) 1 month
Secondary Recurrence Recurrence of urinary retention after catheter removal 24 hours after the removal of the catheter
Secondary 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
7 days
Secondary Late POUR Late post-operative urinary retention Between 6 hours and 24 hours post-op
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