A randomized controlled trial comparing alpha-blocker (tamsulosin) and a phyto-complex (Solidago virga-aurea, Phyllantus niruri, Epilobium angustifolium, Peumus boldus and Ononis spinosa) in the treatment of ureteral stent-related symptoms

Background: Aim of our study is to compare phytotherapy (a combination of extracts of Solidago virga-aurea, Phyllantus niruri, Epilobium angustifolium, Peumus boldus and Ononis spinosa) versus Tamsulosin effect on double J stent-related symptoms. Materials and Methods: Between October 2021 and October 2022, 60 patients undergoing double J stent positioning were randomly divided into 2 (group 1, n: 30, group 2, n: 30). Each patient randomly received Tamsulosin 0.4 mg (one capsule per day, group 1) or phyto-complex (one capsule filled with extracts per day, group 2) for 1 month in an open label setting. Ureteral stent-related morbidity indices including urinary symptom, pain, general health, quality of work, sexual score and additional problems measured by Ureteral Symptom Score Questionnaire (USSQ) at the 1st, 7th and 21st (double J stent removal) day after stent positioning (labeled as Day 1, Day 7, and Day 21, respectively) were evaluated. Results: Although both treatments resulted in an improvement from baseline in each USSQ parameter, the only statistically significant difference between the two groups was detected in terms of urinary symptoms domain of the USSQ at 7 and 21 days (respectively -6.1 +/- 5.5 vs -4.6 +/- 5.1 and -5.2 +/- 6.7 vs -4.4 +/- 5.9) in favor of the tamsulosin group, while no statistically significant differences were detected in terms of improvements in pain, general health, quality of work, sexual score and additional problems (p value >0.05). Conclusions: According to our results, we suggest that this combination of extracts could be as effective as Tamsulosin 0.4 mg to minimize stent-related urinary symptoms and improve general health in patients with double J stent.