Comparison of meloxicam, tamsulosin and combination of both drugs with 16 Fr and 20 Fr catheter on trial without catheter successfulness in patients with benign prostatic hyperplasia
Background: Acute urinary retention, is one of the main complications of Benign Prostatic Hyperplasia (BPH) in elderly patients. Trial Without Catheter (TWOC) is a way to evaluate whether a patient can urinate spontaneously after an episode of urinary retention.
Objective: To prove that the combination of meloxicam 15 mg and tamsulosin 0.4 mg orally once daily for three weeks with 20 Fr catheter is more effective in the TWOC successfulness in BPH patients than meloxicam 15 mg or tamsulosin 0.4 mg alone with 16 Fr catheter.
Methods: Patients BPH who had the first episode of urinary retention and fulfil the inclusion criteria were randomised. There were six treatment groups (n=6). The treatment group are meloxicam 15 mg + catheter 16 Fr (K1), combination of meloxicam 15 mg and tamsulosin 0.4 mg + catheter 16 Fr (K2), tamsulosin 0.4 mg + catheter 16 Fr (K3), meloxicam 15 mg + catheter 20 Fr (K4), combination of meloxicam 15 mg and tamsulosin 0.4 mg + catheter 20 Fr (K5), tamsulosin 0.4 mg + catheter 20 Fr (K6). For each group, drugs were given orally once daily for seven days. Efficacy of TWOC was assessed by the ability of spontaneous urinary after the first 24 hour post urethral catheter treatment, with Q-max result on uroflowmetry = 5 cc/sec and PVR = 100 cc.
Result: All subjects from K1 and K4 experience a recurrent episode of urinary retention (100%), 83.3% in K3 and 66.7% in K6. In the combination group, K2 had 50% incidence of repeat urinary retention, while K5 had16.7%. From the whole group, a statistically significant difference with p <0.05 only can be found in K1 and K5 (p = 0.02).
Conclusion: The combination of meloxicam 15 mg and tamsulosin 0.4 mg + 20 Fr catheter had a better effect in TWOC efficacy compared with the meloxicam 15 mg + catheter 16 Fr group.
Garraway WM, Lee RJ, Collins GN. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991;338(8765):469–71.
Briganti A, Capitanio U, Suardi N, Gallina A, Salonia A, Bianchi M, et al. Benign Prostatic Hyperplasia and Its Aetiologies. european urology supplement. 2009;8(13):865–71. doi.org/10.1590/S1677-5538.IBJU.2015.0254
Roehrborn CG. Benign prostatic hyperplasia?: etiology, pathophysiology, epidemiology, and natural history. In: Campbell-Walsh Urology. 10th ed. Philadelphia: Elsevier Saunders; 2012. p. 2570–610.
Mochtar C. Panduan penatalaksanaan klinis pembesaran prostat jinak (benign prostatic hyperplasia/BPH). ikatan ahli urologi indonesia; 2015.
Nickel JC, Roehrborn CG, Castro-Santamaria R, Freedland SJ, Moreira DM. Chronic Prostate Inflammation is Associated with Severity and Progression of Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms and Risk of Acute Urinary Retention. journal of urology. 2016;196(5):1493–8. doi.org/10.1016/j.juro.2017.01.035
Gandaglia G, Briganti A, Gontero P, Mondaini N, Novara G, Salonia A, et al. The role of chronic prostatic inflammation in the pathogenesis and progression of benign prostatic hyperplasia (BPH). BJU intenational. 2013;112(4):432–41. doi.org/10.1111/bju.12118
Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess H a, et al. Natural history of prostatism: risk factors for acute urinary retention. journal of urology. 1997;158(2):481–7.doi.org/10.1016/S0022-5347(01)64508-7
Mcneill SA. The Role of Alpha-Blockers in the Management of Acute Urinary Retention Caused by Benign Prostatic Obstruction. european urology Journal.2004;45:325–32. doi.org/10.1016/j.eururo.2003.10.001
Schulman CC. Long-term aspects of medical treatment of BPH. european urology. 2001;40(SUPPL. 3):8–12. doi. org/10.1159/000049885
Fitzpatrick JM, Desgrandchamps F, Adjali K, Guerra LG, Hong SJ, El Khalid S, et al. Management of acute urinary retention: A worldwide survey of 6074 men with benign prostatic hyperplasia. BJU international. 2012;109(1):88–95. https://doi.org/10.1111/j.1464-410X.2011.10430.x
Bowden E, Hall S, Foley S, Rundle J. Tamsulosin in the treatment of urinary retention?: a prospective, placebo-controlled trial. BJU international supplement. 2001;88(1):77. doi.org/10.1177/102F102490790801500104
Lucas MG, Stephenson TP, Nargund V. Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia. BJU international. 2005;95(3):354–7. doi.org/10.1111/j.1464-410X.2005.05299.x
Maldonado-Ávila M, Manzanilla-García HA, Sierra-Ramírez JA, Carrillo-Ruiz JD, González-Valle JC, Rosas-Nava E, et al. A comparative study on the use of tamsulosin
versus alfuzosin in spontaneous micturition recovery after transurethral catheter removal in patients with benign prostatic growth. international urology and nephrology. 2014;46(4):687–90. doi.org/10.1007/s11255-013-0515-y
Guang-Jun D, Feng-Bin G, Xun-Bo J. Alpha(1)-blockers in the management of acute urinary retention secondary to benign prostatic hyperplasia: a systematic
review and meta-analysis. Irish journal of medical science. 2015;184(1):23–30. doi.org/10.1007/s11845-014-1094-3
Diseases BPHP, Tuncel A, Uzun B, Eruyar T, Karabulut E, Seckin S, et al.. Do Prostatic Infarction, Prostatic Inflammation and Prostate Morphology Play a Role in Acute Urinary Retention? european urology journal. 2005;48:277–84.doi.org/10.1016/j.eururo.2005.05.001
Kim BH, Kim C Il, Chang HS, Choe MS, Jung HR, Kim DY, et al. Cyclooxygenase-2 overexpression in chronic inflammation associated with benign prostatic hyperplasia:
Is it related to apoptosis and angiogenesis of prostate cancer?. korean journal of urology. 2011;52(4):253–9. doi.org/10.4111/kju.2011.52.4.253
Falahatkar S, Mokhtari G, Pourreza F, Asgari SA, Kamran AN. Celecoxib for Treatment of Nocturia Caused by Benign Prostatic Hyperplasia: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study. urology. 2008;72(4):813–6. doi.org/10.1016/j.urology.2008.04.069
Ozdemir I, Bozkurt O, Demir O, Aslan G, Esen AA. Combination Therapy With Doxazosin and Tenoxicam for the Management of Lower Urinary Tract Symptoms. Urology. 2009;74(2):431–5.doi.org/10.1016/j.urology.2009.01.088
Suarsana W, Hardjowijoto S, Wirjopranoto S, Budiono B. Doxazosin and Meloxicam Combination Therapy for BPH Treatment with LUTS. indonesian journal of urology. 2014;21(1).
Kahokehr A, Vather R, Nixon A, Hill AG. Non-steroidal anti-inflammatory drugs for lower urinary tract symptoms in benign prostatic hyperplasia: Systematic
review and meta-analysis of randomized controlled trials. BJU intrnational 2013;111(2):304–11. doi.org/10.1111/j.1464-410X.2012.11559.x
McNeill SA, Hargreave TB, Roehrborn CG. Alfuzosin 10 mg once daily in the management of acute urinary retention: Results of a double-blind placebo-controlled
study. Urology. 2005;65(1):83–9.doi.org/10.1016/j.urology.2004.07.042
Di Silverio F, Bosman C, Salvatori M, Albanesi L, Proietti Pannunzi L, Ciccariello M, et al. Combination therapy with rofecoxib and finasteride in the treatment of men with Lower Urinary Tract Symptoms (LUTS) and Benign Prostatic Hyperplasia (BPH). european urology. 2005;47(1):72–9. doi.org/10.1016/j.eururo.2004.08.024
Cancio LC, Sabanegh ES, Thompson IM. Managing the Foley catheter. american family physician. 1993;48(5):829–36.(PMID:8213413)
Gorgel SN, Sefik E, Kose O, Olgunelma V, Sahin E. The effect of combined therapy with tamsulosin hydrochloride and meloxicam in patients with benign prostatic hyperplasia symptoms and impact on nocturia and sleep quality. international brazilian journal of urology. 2013;39(5):657–62. doi.org/10.1590/S1677-5538.IBJU.2013.05.07
Chughtai B, Lee R, Te A, Kaplan S. Role of inflammation in benign prostatic hyperplasia. reviews in urology. 2011;13(3):147–50. PMID: 22110398
Masick JM, Levin RM, Hass MA. The effect of partial outlet obstruction on prostaglandin generation in the rabbit urinary bladder. Prostaglandins Other Lipid Mediator. 2001;66(3):211–9. doi.org/10.1016/S0090-6980(01)00151-4
Park JM, Yang T, Arend LJ, Smart a M, Schnermann JB, Briggs JP. Cyclooxygenase-2 is expressed in bladder during fetal development and stimulated by outlet obstruction. American Journal of Physiology. 1997;273:538–44.doi.org/10.1152/ajprenal.1997.273.4.F538
Verhamme KMC, Dieleman JP, Van Wijk M a M, van der Lei J, Bosch JLHR, Stricker BHC, et al. Nonsteroidal anti-inflammatory drugs and increased risk of acute urinary
retention. archive of internal medicine.2005;165(13):1547–51. doi:10.1001/archinte.165.13.1547
Reginster J. A Double-Blind , Three-Week Study to Compare the Efficacy and Safety of Meloxicam 7 . 5 mg and Meloxicam 15 mg in Patients with Rheumatoid Arthritis A
Double-Blind , Three-Week Study to Compare the Efficacy and Safety of Meloxicam 7.5 mg and Meloxicam 15 mg.1996.
Prouse PJ, Bevis PJ, Bluhmki E, Distel M. Evaluation of the safety, tolerability, and efficacy of meloxicam tablets in patients with osteoarthritis. clinical therapy. 1996;18(3):429–39. doi.org/10.1016/S0149-2918(96)80023-3
Gates BJ, Nguyen TT, Setter SM, Davies NM. Meloxicam: a reappraisal of pharmacokinetics, efficacy and safety. Expert opinion on pharmacotherapy. 2005;6(12):2117–40. doi.org/10.1517/14656518.104.22.1687