title: Randomized controlled trial of the efficacy of isosorbide-SR addition to current treatment in medical expulsive therapy for ureteral calculi.
abstract: It has been suggested that nitrates are potent smooth muscle relaxants that may reduce pain and facilitate ureteral stone passage; therefore it may be an option for medical expulsive therapy in ureteral stones. In a prospective randomized controlled clinical trial, we evaluated the efficacy of medical expulsive therapy with isosorbide-SR 40 mg in patients with ureteral stones (≤10 mm). The patients with ureteral stones in KUB or urinary tract ultrasonography were randomized to receive methylprednisolone plus celecoxib without (control group), and with isosorbide-SR 40 mg (treatment group) for 21 days. 66 patients [33(50%) in control, 33(50%) in treatment group] were entered randomly to our study. The stone expulsion rate was not significantly different between two groups (54.5 vs. 45.5%) (P = 0.497). The need for surgical procedures were more common in control group within 21 days (9.4 vs. 6.1%) and more common in treatment group after 21 days (33.3 vs. 21.9%) (P = 0.756).Patients in the treatment group experienced more intractable pain (27.3 vs. 6.1%), intractable vomiting (3 vs. 0%) (P = 0.046) and hospitalization (3 vs. 0%) (P = 0.314). Drug side effects including headache and dizziness were more common in treatment group (39.4 vs. 9.1%) (P = 0.004). In our study, the use of isosorbide-SR in treatment group did not improve the stone expulsion rate in patients with ureteral stones (≤10 mm) but developed more side effects. Then it may not an appropriate alternative for medical expulsive therapy. Of course, further trials are recommended.
authors.affiliation: Urology Research Center, Razi Hospital, Guilan University of Medical Sciences, Rasht, Guilan, Iran. a42hamidi2000@yahoo.com
authors.forename: Ali
authors.initials: A
authors.lastname: Hamidi Madani
authors.forename: Majid
authors.initials: M
authors.lastname: Kazemzadeh
authors.forename: Farshid
authors.initials: F
authors.lastname: Pourreza
authors.forename: Maryam
authors.initials: M
authors.lastname: Shakiba
authors.forename: Alireza
authors.initials: A
authors.lastname: Farzan
authors.forename: Ahmad
authors.initials: A
authors.lastname: Asadollahzade
authors.forename: Samaneh
authors.initials: S
authors.lastname: Esmaeili
mesh_terms: D000328:Adult; D000068579:Celecoxib; D003692:Delayed-Action Preparations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007547:Isosorbide / Q000008:administration & dosage*; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage; D008875:Middle Aged; D010276:Parasympatholytics / Q000008:administration & dosage; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage; D013449:Sulfonamides / Q000008:administration & dosage; D016896:Treatment Outcome; D014514:Ureteral Calculi / Q000188:drug therapy*
chemical_list: D003692:Delayed-Action Preparations; D010276:Parasympatholytics; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D007547:Isosorbide; D008775:Methylprednisolone