To evaluate the effect of tamsulosin and tamsulosin+ solifenacin combination therapy in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents.
Study design: Prospective observational comparative study
Place and duration of study: Department of urology & Renal transplantation (dr. psims and rf) from March 2019 to October 2020.
Methods: Total 100 patients having lower urinary tract symptoms after DJ stent insertion were selected for the study. DJ stenting was done in these patients following ureterorenoscopy (URS) and intracorporeal lithotripsy, percutaneous nephrolithotomy (PCNL), ureterolithotomy, pyelolithotomy, pyeloplasty and in patients with obstructive uropathy. All the patients were allocated two different groups. Group A received Tamsulosin 0.4 mg & Group B received Tamsulosin 0.4 mg and Solifenacin 5 mg daily once a day every day. The IPSS questionnaire was filled on day of per urethral catheter removal and on the day of DJ stent removal. Results were made on the day of DJ stent removal by comparing the mean change in IPSS in both groups. Independent sample t-test and paired t-test were applied. P-value < 0.05 was taken as significant.
Result: Mean age was 41.6±13.75 years in Group-A and 38.24±12.24 years in Group-B. Total number of male patients was 25 (50%) in Group-A and 31 (62%) in Group-B. Female patients in Group-A were 25 (50%) and 19 (38%) in Group-B. Mean IPSS was 9.32 ±2.39 in Group-A and 9.52 ±3.39 in Group-B at baseline (p=0.62). After 2 weeks IPSS was 3.98 ±1.74 in Group-A and 2.36 ±1.51 in Group-B (p=0.0001). There was a statistically significant difference between group A and group B in the IPSS score.
Trial registration: The study protocol was registered on Clinical Trials Registry- India (ICMR-NIMS) on April 30th, 2020 (registration number: CTRI/2020/04/024945).
Conclusions: The mean change in IPSS by combined treatment of Tamsulosin and Solifenacin was significant when compared to Tamsulosin alone in treatment of DJ stents related LUTS.