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Efficacy of Tadalafil on Lower Urinary Tract Symptoms of Patients with Ureteral Stents: A Study Protocol for a Randomized Controlled Trial

Abbas Jabbari, S. Hajebrahimi, H. S. Bazargani, Alirza Farshi, H. Babaei

2015

Abstract

ABSTRACT Objectives: Ureteral stenting is a common intervention in endourological procedures. Despite the usefulness of stents, patients may experience various stent-related symptoms. These symptoms can have a significant impact on patients’ health related quality of life. There are several medical modalities for symptom improvement and Phosphodiesterase 5 Inhibitors are recent therapeutic option. This study is designed to evaluate the effects of Tadalafil on alleviation of stent associated symptoms measured by Ureteral Stents Symptom Questionnaire. Design: In this Randomized Controlled Trail patients were randomly assigned to an intervention or Placebo group by a computer based random block design. Patients received encoded drug packages from a central call system. Physicians, patients and statistical analyzers were not aware of the designated intervention. Setting and Conduct: Patients received treatment with Tadalafil or placebo for four weeks after ureteral stent insertion and completed a follow up session four weeks after the intervention.

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.

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