Not Yet RecruitingPhase 4ACTRN12616001348448

Comparing a-blocker against combination therapy, a-blocker plus Prostenoa, for male non-neurogenic lower urinary tract symptoms treatment.

Evaluating the efficacy of combination scheme a-blocker plus Prostenoa against a-blocker alone for the treatment male non-neurogenic lower urinary tract symptoms.


Sponsor

University of Thessaly

Enrollment

200 participants

Start Date

Oct 17, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: MalesMin Age: 35 YearssMax Age: 85 Yearss

Inclusion Criteria1

  • Male patients with non-neurogenic lower urinary tract symptoms and International Prostate Symptoms Score over 10.

Exclusion Criteria3

  • Treatment discomfort
  • Neurogenic male urinary symptoms
  • Prostate cancer

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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 o

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. .


Locations(1)

Thessaly, Greece

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ACTRN12616001348448