Efficacy of combination therapy tadalafil plus tamsulosin in ureteral stents-related symptoms relief
Abstract
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 14th 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 279 participants or records.
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