Comparison between tadalafil 5 MG VS. serenoa repens/selenium/lycopene for the treatment of benign prostatic lower urinary tract symptoms secondary to benign prostatic hyperplasia. a phase IV, randomized, multicenter, non‐inferiority clinical study. sprite study.: MP09‐04
Abstract
Tadalafil is one of the PDE5 inhibitors, and was reported to have prominent beneficial effects on subjects in some studies.However, to the best of our knowledge, the objective effects of this drug on storage and voiding function based on a urodynamic study (UDS) have not yet been reported.In this study, we investigated the effects of tadalafil on storage function and bladder outlet obstruction (BOO) based on a UDS in patients with LUTS due to BPE.METHODS: This open-label, single-center prospective study recruited 65 outpatients with untreated BPE.The patients received tadalafil 5 mg a day for 12 weeks.Before and 12 weeks after drug administration, International Prostate Symptom Score (IPSS), IPSSquality of life (QOL), and Overactive Bladder Symptom Score (OABSS) were used for assessing subjective symptoms.To evaluate storage function, first desire to void (FDV), maximum cystometric capacity (MCC), and the incidence of detrusor overactivity (DO) were measured, while the maximum flow rate (Qmax), detrusor pressure at Qmax (PdetQmax), post-void residual urine (PVR), and BOO index (BOOI) were assessed as parameters of voiding function.RESULTS: A total of 60 patients with a mean age of 70.1 years and mean prostate volume of 46.7 mL were included in the analysis.Subjective symptom parameters such as IPSS, IPSS-QOL, and OABSS improved significantly at 12 weeks after treatment.In the storage phase of UDS, FDV and MCC significantly increased.Besides, out of 33 patients with DO before…
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: 60 participants or records.
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