None listed
Conditions
Brief summary
The aim of tis study is to evaluate the efficacy of the combination therapy of a-blocker plus Prostenoa for the treatment of non-neurogenic lower urinary tract symptoms in male patients, comparing to a-blocker alone. Patients will be allocated in two Groups. Group 1 will receive the monotherapy, while Group 2 will receive the combination therapy. Patients will be evaluated after 6 and 12 months, based on International Prostate Symptoms Score, Post Void Residual and Quality of Life.
Interventions
Patients with lower urinary tract symptoms due to BPH will be randomized to receive either oral tablet of any kind of a-blocker (determined by treating doctor) once daily for 6 months or oral tablet of any kind of a-blocker (determined by treating doctor) plus oral capsule of Prostenoa once daily for six months. Monitoring, including International Prostate Symptoms Score, Post Void Residual, and Quality of Life based on SF 36, will take place at 6 and 12 months, after treatment beginning
Recievi
Patients with lower urinary tract symptoms due to BPH will be randomized to receive either oral tablet of any kind of a-blocker (determined by treating doctor) once daily for 6 months or oral tablet of any kind of a-blocker (determined by treating doctor) plus oral capsule of Prostenoa once daily for six months. Monitoring, including International Prostate Symptoms Score, Post Void Residual, and Quality of Life based on SF 36, will take place at 6 and 12 months, after treatment beginning Recieving treatment checking will be based on drug tablet return. Prostenoa is a nutricion supplement conisting of Serenoa repens 320mg, Cucurbita pepo 505mg, Lycopenium 0.3mg and Selenium 28mcg per tablet. .
Sponsors
University of Thessaly
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Male patients with non-neurogenic lower urinary tract symptoms and International Prostate Symptoms Score over 10.
Exclusion criteria
Treatment discomfort Neurogenic male urinary symptoms Prostate cancer
Outcome results
None listed