PURPOSE: Based on efficacy demonstrated in the adult population, tamsulosin was evaluated with regard to facilitating ureteral stone expulsion in children presenting with distal ureteric calculi. PATIENTS AND METHODS: A prospective randomized controlled study involving 61 children with distal ureteric calculi <12 mm was performed. The children were randomly divided into two groups. Group I (study group, n = 33) received tamsulosin and standard analgesia, and Group II (placebo group, n = 28) received standard analgesia and placebo. Patients were offered a closely monitored trial for spontaneous stone passage in the 4-week period prior to definitive therapy. The stone expulsion rate, number and duration of pain episodes, need for analgesia and possible side effects of medications were observed. RESULTS: All patients completed the study and none were excluded due to side effects. No significant differences were found between the groups for age, gender and stone size. Mean patient age was 8.1 ± 6.8 years. There were 25 females and 36 males. The stone-free rate was 87.8% in Group I (29/33), compared with 64.2% (18/28) in Group II. A mean stone expulsion time of 8.2 and 14.5 days was recorded for Group I and II respectively, and this difference was statistically significant (P < 0.001). CONCLUSIONS:Medical expulsion therapy for lower ureteric stones is a successful procedure in children. Tamsulosin demonstrated no clinically significant adverse effect, while proving to be a safe and effective treatment option.
RCT Entities:
PURPOSE: Based on efficacy demonstrated in the adult population, tamsulosin was evaluated with regard to facilitating ureteral stone expulsion in children presenting with distal ureteric calculi. PATIENTS AND METHODS: A prospective randomized controlled study involving 61 children with distal ureteric calculi <12 mm was performed. The children were randomly divided into two groups. Group I (study group, n = 33) received tamsulosin and standard analgesia, and Group II (placebo group, n = 28) received standard analgesia and placebo. Patients were offered a closely monitored trial for spontaneous stone passage in the 4-week period prior to definitive therapy. The stone expulsion rate, number and duration of pain episodes, need for analgesia and possible side effects of medications were observed. RESULTS: All patients completed the study and none were excluded due to side effects. No significant differences were found between the groups for age, gender and stone size. Mean patient age was 8.1 ± 6.8 years. There were 25 females and 36 males. The stone-free rate was 87.8% in Group I (29/33), compared with 64.2% (18/28) in Group II. A mean stone expulsion time of 8.2 and 14.5 days was recorded for Group I and II respectively, and this difference was statistically significant (P < 0.001). CONCLUSIONS: Medical expulsion therapy for lower ureteric stones is a successful procedure in children. Tamsulosin demonstrated no clinically significant adverse effect, while proving to be a safe and effective treatment option.
Authors: Jonathan S Ellison; Paul A Merguerian; Benjamin C Fu; Sarah K Holt; Thomas S Lendvay; John L Gore; Margarett Shnorhavorian Journal: J Pediatr Urol Date: 2017-04-20 Impact factor: 1.830