PD24-01 double blind, randomized, placebo controlled study of tadalafil with dutasteride versus tadalafil with placebo for lower urinary tracts symptoms secondary to benign prostatic hyperplasia: a single centre study
Abstract
INTRODUCTION AND OBJECTIVES: An important reason for lower urinary tract symptoms (LUTS) in elderly men is Benign Prostatic Hyperplasia (BPH). Erectile dysfunction (ED) also has a negative effect on quality of life (QoL) also a major problem at this age. Dutasteride decreases the size of the prostate but has sexual problems, impotence as an adverse effect. These may be nullified with Tadalafil which used in the treatment of impotence and erectile dysfunction. It also has a proven beneficial effect in BPH. Aim: To assess the efficacy of Tadalafil with Dutasteride and Tadalafil with placebo for LUTS secondary to BPH Primary objective: To evaluate the effect of Tadalafil with Dutasteride combination therapy as compared to Tadalafil with placebo on patients with LUTS due to BPH, objectively Secondary Objective: To assess the safety profile of Tadalafil with Dutasteride combination therapy as compared to Tadalafil with placebo on patients with LUTS due to BPH. METHODS: Study design: A prospective, double-blind, randomized, placebo-controlled study (n=30) patients enrolled in each group. Sample size generated from Power and Sample size calculation program (Version 3.0) using with Statistical Power (1-&bgr;) = 0.85 and Level of Significance (&agr;) = 0.05. Student’s t-test used. Period of study: February 2016 to December 2016 Dose and duration of study drugs Tadalafil 5mg, Dutasteride 0.5mg, duration 6 months. RESULTS: ‘Dutasteride + Tadalafil arm’ (D+T) and ‘Tadalafil+ placebo…
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: 30 participants or records.
Read the paper
Related studies
- Treatment of non-metastatic castration-resistant prostate cancer: facing age-related comorbidities and drug–drug interactions
- The Efficacy of Flogofilm® in the Treatment of Chronic Bacterial Prostatitis as an Adjuvant to Antibiotic Therapy: A Randomized Prospective Trial
- Inhibition of growth and contraction in human prostate stromal cells by silencing of NUAK1 and -2, and by the presumed NUAK inhibitors HTH01-015 and WZ4003
- Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study
- Extract from Cucurbita pepo improves BPH symptoms without affecting sexual function: a 24-month noninterventional study
- Aquablation vs. holmium laser enucleation of the prostate for benign prostatic hyperplasia: a 150-patients prospective comparative multicenter study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.