Efficacy of tamsulosin hydrochloride in relieving "double-J ureteral stent-related morbidity": a randomized placebo controlled clinical study. 2014

Iqbal Singh, and Sambit Tripathy, and Vivek Agrawal
Department of Surgery, University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, 110095, India, iqbalsinghp@yahoo.co.uk.

OBJECTIVE To evaluate the efficacy of tamsulosin therapy in reducing ureteral double-J stent morbidity by evaluating USSQ, IPSS, QOL and VAS (primary objective) and to evaluate the morbidity and or complication(s) associated with indwelling double-J ureteral stent(s) and to evaluate the safety of tamsulosin therapy for "morbidity associated with double-J stents" by evaluating its tolerability, side effects and adverse events if any (secondary objective) as per protocol. METHODS After institutional review board approval, 60 consecutive patients with a double-J ureteral stent inserted after percutaneous nephrolithotomy or ureteroscopic stone treatment were randomly assigned to receive tamsulosin 0.4 mg, or a placebo for 4 weeks. The validated USSQ, VAS and IPSS were completed before stent insertion, at 3 days and 4 weeks after stent insertion and at 2 weeks after stent removal. Data were statistically analyzed for efficacy and tolerability of one drug over the other using Wilcoxon signed-rank test, Mann-Whitney test and Student's t test. RESULTS Patients receiving tamsulosin compared with the placebo showed significant decrease in urinary index score, pain index score, work performance score, VAS score at loin area, VAS score at flank, VAS score at suprapubic area, average VAS score, need for antibiotics, number of hospital visits (P < 0.05) at the end of fourth weeks. Decrease in values were also observed in IPSS score, general health score, quality of sex score and IPSS-quality of life (QOL) score in patients taking tamsulosin but, however, the decrease was not significant. No patients discontinued medication because of side effects. CONCLUSIONS We conclude that ureteral stenting using double-J stents with concomitant tamsulosin therapy was generally well tolerated, safe, effective and significantly beneficial in reducing stent morbidity in the majority of our patients. We advocate the routine use of concomitant tamsulosin therapy in eligible patients undergoing ureteral stenting in order to minimize stent morbidity.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010147 Pain Measurement Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies. Analgesia Tests,Analogue Pain Scale,Formalin Test,McGill Pain Questionnaire,Nociception Tests,Pain Assessment,Pain Intensity,Pain Severity,Tourniquet Pain Test,Visual Analogue Pain Scale,Analog Pain Scale,Assessment, Pain,McGill Pain Scale,Visual Analog Pain Scale,Analgesia Test,Analog Pain Scales,Analogue Pain Scales,Formalin Tests,Intensity, Pain,Measurement, Pain,Nociception Test,Pain Assessments,Pain Intensities,Pain Measurements,Pain Questionnaire, McGill,Pain Scale, Analog,Pain Scale, Analogue,Pain Scale, McGill,Pain Severities,Pain Test, Tourniquet,Questionnaire, McGill Pain,Scale, Analog Pain,Scale, Analogue Pain,Scale, McGill Pain,Severity, Pain,Test, Analgesia,Test, Formalin,Test, Nociception,Test, Tourniquet Pain,Tests, Nociception,Tourniquet Pain Tests
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000077409 Tamsulosin A sulfonamide derivative and adrenergic alpha-1 receptor antagonist that is used to relieve symptoms of urinary obstruction caused by BENIGN PROSTATIC HYPERPLASIA. 5-(2-((2-(2-Ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide,Flomax,LY 253352,LY-253352,Tamsulosin Hydrochloride,YM 617,YM-617
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths

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