Introduction
Ureteral stents-related symptoms (USRs) are the common complications of ureteral stenting. Tamsulosin a selective alpha-1 blocker and Tadalafil a PDE-5 inhibitor are one of drugs have been used for USRs relief. In this study we aimed to evaluate the effectiveness and safety of combination therapy Tamsulosin+Tadalafil for treating USRs comparing it with the efficacy of either Tamsulosin or Tadalafil monotherapies.
Material and methods
279 patients with indwelled unilateral ureteral stents were randomized to Tamsulosin 0.4 mg + Tadalafil 5 mg once a day (Group 1, n = 67), Tamsulosin 0.4 mg once a day (Group 2, n = 71), Tadalafil 5 mg once a day (Group 3, n = 69) and Placebo once a day (Group 4, n = 72). USRs severity was registered and calculated by using the Ureteral Symptoms Score Questionnaire (USSQ) at the 14
th
day of treatment. Side-effects and total analgesic use were recorded and compared.
Results
At the endpoint in patients with unilateral ureteral stents the combination therapy Tamsulosin + Tadalafil led to statistically lower intensity of urinary symptoms comparing with Tamsulosin (15.2 ±4.3 vs 21.8±3.6, p = 0.0003) or Tadalafil (15.2 ±4.3 vs 20.6 ±2.8, p = 0.0004) monotherapy. All groups of treatment demonstrated significant relief of USRs comparing with Placebo mostly beneficial in the combined therapy group. Body pain and analgesic need in Group 1 was lower than in Groups 2, 3 or 4. Side-effects were registered rarely without statistical differences in frequency between groups.
Conclusions
Combination therapy with Tamsulosin + Tadalafil is an effective and safe option that achieves the statistically more significant relief of USRs comparing with Tadalafil or Tamsulosin monotherapies.