DOI: http://dx.doi.org/10.18203/2320-6012.ijrms20191523

Efficacy and safety of tadalafil in ureteric stent related symptoms: a double blind, prospective, randomised study

Vinod K. Chauhan, Manish K. Singla, Anuj Dumra, Nitin Agarwal, Amarpreet S. Bawa

Abstract


Background: Is tadalafil effective and safe in ureteric stent related symptoms? The objective of this trial is to study the efficacy and safety of tadalafil and compare it with tamsulosin in relieving ureteric stent related symptoms by using ureteral stent symptom questionnaire.

Methods: Total 144 patients with dj stent symptoms were randomized into two groups with 72 patients in each. Group A patients were given tadalafil 5mg and Group B, tamsulosin 0.4mg for 2 weeks. Ureteral stent symptom questionnaire was filled on 7th day and on 21st day after stent insertion. Statistically significant difference between groups was determined by the t-test, Mann-Whitney U-test, Pearson Chi-square test or Fisher's exact test. Comparison between quantitative time related variables was done by Wilcoxon Signed Rank test. All the statistical tests were two-sided and were performed at a significance level of α=.05.

Results: Tamsulosin was found more effective then tadalafil in decreasing mean urinary index (p=0.004). Tadalafil caused significant decrease in body pain (p=0.006) and improvement in general health index score, work performance and sex score (P value= 0.041, <0.001 and <0.015 respectively) as compared to tamsulosin. Additional problems score improvement and analgesic use were found comparable in 2 groups (p value =0.193, 0.070 respectively). Adverse effect with both the drugs were minimal, mild to moderate and self-limiting.

Conclusions: Tadalafil found more effective then Tamsulosin in relieving body pain, sexual symptoms and improving general health and work performance but less effective in improvement of urinary symptoms.


Keywords


Tadalafil, Tamsulosin, Ureteral stent symptom questionnaire

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References


Zimskind PD, Fetter TR, Wilkerson JL. Clinical use of long-term indwelling silicone rubber ureteral splints inserted cystoscopically. J Urol. 1967;97:840-4.

Carlos E, Probst M, Razvi H, Denstedt JD. Fundamentals of instrumentation and urinary tract drainage. Campbell-Walsh Urology. In: Kavoussi LR, Partin AW, Peters CA, Editors. 10th ed. Elsevier, Philadelphia, PA, USA; 2012:183.

Chew BH, Knudsen BH, Denstedt D. The use of stents in contemporary urology. Curr Opin Urol. 2004;14:111-5.

Jeong H, Hwak C, Lee SE. Ureteric stenting after ureteroscopy for ureteric stones: a prospective randomized study assessing symptoms and complications. BJU Int. 2004;93:1032-5.

Joshi HB, Okeke A, Newns N, Keeley FX, Jr, Timoney AG. Characterization of urinary symptoms in patients with ureteral stents. Urol. 2002;59:511-9.

Joshi HB, Stainthorpe A, Macdonagh RP, Keeley FX, Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: Evaluation of symptoms, quality of life and utility. J Urol. 2003;169:1065-9.

Al-Kandari AM, Al-Shaiji TF, Shaaban H, Ibrahim HM, Elshebiny YH, Shokeir AA. Effects of proximal and distal ends of double-j ureteral stent position on post procedural symptoms and quality of life: a randomized clinical trial. J Endourol. 2007;21:698-702.

Ramsay JW, Payne SR, Gosling PT, Whitfield HN, Wickham JE, Levison DA. Effects of double-J stenting on unobstructed ureter: an experimental and clinical study. Br J Urol. 1985;57:630-4.

Mosli H, Farsi H, Al-Zemaity MF, Saleh TR, Al-Zamzami MM. Vesico-ureteral reflux in patients with double pigtail stents. J Urol. 1991;146:966-9.

Saltzman B. Ureteral stents: indications, variations and complications. Urol Clin N Am. 1988;15:481-91.

Joshi HB, Newns MN, Stainthorpe A, MacDonagh RP, Keeley FX, Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003;169:1060-4.

Ho CH, Chen SC, Chung SD, Lee YJ, Chen J, Yu HJ, et al. Determining the Apropriate Length of a Double-Pigtail Ureteral Stent by Both Stent Configurations and Related Symptoms. J Endourol. 2008;22:1427-31.

Cadieux PA, Chew BH, Knudsen BE, Dejong K, Rowe E, Reid G, et al. Triclosan loaded ureteral stents decrease Proteus mirabilis 296 infection in a rabbit urinary tract infection model. J Urol. 2006;175:2331.

Riedl CR, Witkowski M, Plas E, Pflueger H. Heparin coating reduces encrustation of ureteral stents: A preliminary report. Int J Antimicrob Agents. 2002;19:507-10.

Multanen M, Tammela TL, Laurila M, Seppälä J, Välimaa T, Törmälä P, et al. Biocompatibility, encrustation and biodegradation of ofloxacine and silver nitrate coated poly-L-lactic acid stents in rabbit urethra. Urol Res. 2002;30:227-32.

Watterson JD, Cadieux PA, Beiko DT, Cook AJ, Burton JP, Harbottle RR, et al. Oxalate-degrading enzymes form Oxalobacterformigenes: A novel device coating to reduce urinary tract biomaterial-related encrustation. J Endourol. 2003;17:269-74.

Beiko DT, Knudsen BE, Denstedt JD. Advances in ureteral stent design. J Endourol. 2003;17:195-9.

Dunn MD, Portis AJ, Kahn SA, Yan Y, Shalhav AL, Elbahnasy AM, et al. Clinical effectiveness of new stent design: randomized single-blind comparison of tail and double pig-tail stents. J Endourol. 2000;14:195-202.

Mardis HK. Standard specification for ureteral stents: A comparative evaluation of newer devices. J Urol. 2001;165:362.

Lumiaho J, Heino A, Pietiläinen T, Ala-Opas M, Talja M, Välimaa T, et al. The morphological, in situ effects of a self-reinforced bioabsorbable polylactide (SR-PLA 96) ureteric stent; an experimental study. J Urol. 2000;164(4):1360-3.

Andersson KE. Antimuscarinic mechanisms and the overactive detrusor: An update. Eur Urol. 2011;59:377-86.

Lee YJ, Huang KH, Yang HJ, Chang HC, Chen J, Yang TK. Solifenacin improves double-J stent-related symptoms in both genders following uncomplicated ureteroscopic lithotripsy. Urolithiasis. 2013;41(3):247-52.

Shalaby E1, Ahmed AF, Maarouf A, Yahia I, Ali M, Ghobish A. Randomized controlled trial to compare the safety and efficacy of tamsulosin, solifenacin, and combination of both in treatment of double-j stent-related lower urinary symptoms. Adv Urol. 2013;2013:752382.

Tehranchi A, Rezaei Y, Khalkhali H, RezaeiM. Effects of terazosin and tolterodine on ureteral stent related symptoms: a double-blind placebo-controlled randomized clinical trial. Int Braz J Urol. 2013;39(6):832-40.

Dellabella M, Milanese G, Muzzonigro G. Efficacy of tamsulosin in the medical management of juxtavesical ureteral stones. J Urol. 2003;170:2202.

Andersson KE, Gratzke C. Pharmacology of alpha1-adrenoceptor antagonists in the lower urinary tract and central nervous system. Nat Clin Pract Urol. 2007;4:368-78.

Rossi M, Roumegue`re T. Silodosin in the treatment of benign prostatic hyperplasia. Drug Des Devel Ther. 2010;4:291-7.

Sigala S, Dellabella M, Milanese G et al. Evidence for the presence of alpha1 adrenoceptor subtypes in the human ureter. Neurourol. Urodyn. 2005;24:142.

Deliveliotis C, Chrisofos M, Gougousis E, Papatsoris A, Dellis A, Varkarakis IM. Is there a role for alpha1-blockers in treating double-J stent-related symptoms? Urol. 2006;67:35-9.

Singh I, Tripathy S, Agrawal V. Efficacy of tamsulosin hydrochloride in relieving double-J ureteral stent-related morbidity: a randomized placebo controlled clinical study. Int Urol Nephrol. 2014;46(12):2279-83.

Wang CJ, Huang SW, Chang CH. Effects of tamsulosin on lower urinary tract symptoms due to double-J stent: a prospective study. Urol Int. 2009;83(1):66-9.

Dellis AE, Keeley FX Jr, Manolas V, Skolarikos AA. Role of α-blockers in the treatment of stent-related symptoms: a prospective randomized control study. Urology. 2014 Jan;83(1):56-61.

Gratzke C, Uckert S, Kedia G, Reich O, Schlenker B, Seitz M, et al. In vitro effects of PDE5 inhibitors sildenafil, vardenafil and tadalafil on isolated human ureteral smooth muscle: a basic research approach. Urol Res. 2007;35:49-54.

Uckert S, Oelke M. Phosphodiesterase (PDE) inhibitors in the treatment of lower urinary tract dysfunction. Br J Clin Pharmacol. 2011;72(2):197-204.

Jayant K, Agarwal R, Agarwal S. Tamsulosin versus tamsulosin plus tadalafil as medical expulsive therapy for lower ureteric stones: a randomised controlled trial. Int J Urol. 2014 Oct;21(10):1012-5.

Hajebrahimi S, Farshi A, Jabbari A, Bazargani HS, Babaei H, Mostafaie H. 1080 Does tadalafil alleviate ureteral stent related symptoms? A randomized controlled trial. European Urol Supplements. 2015 Apr 1;14(2):e1080.

Aggarwal SP, Priyadarshi S, Tomar V, Yadav SS, Gangkak G, Vyas N, et al. A randomized controlled trial to compare the safety and efficacy of tadalafil and tamsulosin in relieving double J stent related symptoms. Adv Urol. 2015;2015.