Hypothesis / aims of study
The clinical usage of the ureteral stent caused stent-related symptoms (sRS). The complaint is equal to Lower Urinary Tract Symptoms (LUTS) and overactive bladder (OAB). This study investigated the efficacy of mirabegron, solifenacin, tamsulosin, tadalafil, and their combination in patients with Double-J Stent-Related Lower Urinary Tract Symptoms that were divided into 7 groups of therapy.
Study design, materials and methods
This double-blind randomized clinical trial used consecutive random sampling to select 161 participants with Double-J Stent-Related Lower Urinary Tract Symptoms. All patients randomized in 1:1 ratio to receive mirabegron 50 mg (grup A), solifenacin 5 mg (Grup B), tamsulosin 0,4 mg (grup C), tadalafil 10 mg (grup D), combination of mirabegron 25 mg + 5 mg solifenacin (grup E), combination of tamsulosine 0,4 mg + solifenacin 5 mg (grup F) and placebo (grup G). Each subject was given paracetamol as an analgesic. The Ureteral Stent Symptoms Questionnaire (USSQ) was used to compare treatment outcomes by six indices (urinary symptoms, pain symptoms, general health conditions, working performance, sexual matters, and additional problems) was administered on the 7th, 14th, 21st, and 28th day after the insertion of the ureteral stent. The data were analyzed using the ANOVA test, with p values of <0.05 were considered to be statistically significantly.
Results
All 7 groups of therapy were statistically significant over 4 weeks. Each group consists of 24 samples except placebo only 17 samples.
Tamsulosin has the highest score (8.95) to reduce urinary symptoms, and the lowest score was on Tamsulosin + Solifenacin (2.5), where the most decreased complaints based on scores were Tamsulosin + Solifenacin (19.12) and the least reducing score is Mirabegron (7.62). On the Pain questionnaire, the highest score at week IV was on Tamsulosin (5.25), the lowest score was on Tadalafil, and the most reducing complaints based on scores was Tamsulosin + Solifenacin (17.83) and the least reducing scores was Placebo (7.11). In General Conditions the highest score at week IV was on Mirabegron (5.39), the lowest score was Tadalafil (0.45), and the most reducing complaints based on scores was Tadalafil (9.71) and the least lowering score is Mirabegron (3.34). Placebo has the highest score (4.41) in week IV, the lowest score on Tamsulosin + Solifenacin (0.2), where the most reducing complaints based on the score was Tamsulosin + Solifenacin (6.50) and the one that lowers the score the least is Placebo (1.76) (4.41), on Sexual Activity the highest score at week IV was on Mirabegron + Solifenacin (2.04), the lowest score was on Tamsulosin + Solifenacin (0), where the most reducing complaints based on scores was Tadalafil (1.42) and The least decrease in score was Mirabegron (0.17), but the one whose complaints increased was Solifenacin (score increased 0.87). And the last is Other Complaints with the highest score at week IV being on Mirabegron (4.00), the lowest score was on Tamsulosin+Solifenacin (0.45), where the most decreased complaints based on scores were Tadalafil (5.66) and the least reducing score is Mirabegron (1.83).
A combination of Tamsulosin and Solifenacin shows the lowest USSQ score on urinary symptoms, working performance, sexual matters, and additional problems. However, on pain symptoms and general health condition, Tadalafil shows the lowest USSQ score compared to others.
Interpretation of results
The combination of Tamsulosin and Solifenacin had better results to resolve urinary symptoms, working performance, sexual matters, and additional problems. On pain symptoms and general health conditions, Tadalafil had a better result than others.