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

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.
Participants: Male patients who underwent unilateral ureteral stenting in Imam Reza hospital in Tabriz, Iran were enrolled in this study. Patients with history of hypertension, heart and/or respiratory disease, stroke, hypotension, renal failure, consumption of nitrate drugs and a positive urine culture or who had any allergic reaction to Tadalafil were excluded.
Interventions: Patients were allocated to receive Tadalafil 10 mg or Placebo daily for four weeks.
Outcome Variables: The primary outcome variables were stent related symptoms (urinary symptoms, pain, general health, sex and working status). Secondary outcomes included possible side effects such as cardiovascular, respiratory, gastrointestinal, musculoskeletal and central nervous system problems.