Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001348448
Ethics application status
Approved
Date submitted
5/09/2016
Date registered
27/09/2016
Date last updated
5/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing a-blocker against combination therapy, a-blocker plus Prostenoa, for male non-neurogenic lower urinary tract symptoms treatment.
Scientific title
Evaluating the efficacy of combination scheme a-blocker plus Prostenoa against a-blocker alone for the treatment male non-neurogenic lower urinary tract symptoms.
Secondary ID [1] 290097 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-neurogenic lower urinary tract symptoms in males 300184 0
Condition category
Condition code
Renal and Urogenital 300068 300068 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.



.
Intervention code [1] 295832 0
Treatment: Drugs
Comparator / control treatment
Prostenoa plus any a-blocker / control treatment
Control group
Active

Outcomes
Primary outcome [1] 299538 0
International Prostate Symptoms Score (IPSS)
Timepoint [1] 299538 0
Baseline, 6 and 12 months after start of treatment
Primary outcome [2] 299603 0
Post Void Residual (Bladder Ultrasound)
Timepoint [2] 299603 0
Baseline, 6 and 12 months after start of treatment
Primary outcome [3] 299604 0
Quality of life (SF 36)
Timepoint [3] 299604 0
Baseline, 6 and 12 months after start of treatment
Secondary outcome [1] 327472 0
None
Timepoint [1] 327472 0
None

Eligibility
Key inclusion criteria
Male patients with non-neurogenic lower urinary tract symptoms and International Prostate Symptoms Score over 10.
Minimum age
35 Years
Maximum age
85 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment discomfort

Neurogenic male urinary symptoms

Prostate cancer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
www.randomizer.org, central randomization by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/10/2016
Actual
Date of last participant enrolment
Anticipated
1/09/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 8193 0
Greece
State/province [1] 8193 0
Thessaly

Funding & Sponsors
Funding source category [1] 294465 0
University
Name [1] 294465 0
University of Thessaly
Country [1] 294465 0
Greece
Primary sponsor type
University
Name
University of Thessaly
Address
Mezourlo

41100

Larissa
Country
Greece
Secondary sponsor category [1] 293331 0
None
Name [1] 293331 0
Address [1] 293331 0
Country [1] 293331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295895 0
Scientific Committee University Hospital of Larisa
Ethics committee address [1] 295895 0
Ethics committee country [1] 295895 0
Greece
Date submitted for ethics approval [1] 295895 0
01/08/2016
Approval date [1] 295895 0
08/08/2016
Ethics approval number [1] 295895 0
30026

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68838 0
Prof Tzortzis Vasileios
Address 68838 0
Urology Profesor, Urology Department of University of Thessaly
Viopolis Mezourlo
41100
Larisa
Country 68838 0
Greece
Phone 68838 0
+302413502811
Fax 68838 0
Email 68838 0
[email protected]
Contact person for public queries
Name 68839 0
Dr Michael Samarinas
Address 68839 0
Urologist, Urology Department of University of Thessaly
Viopolis Mezourlo
41100
Larisa
Country 68839 0
Greece
Phone 68839 0
+306946006798
Fax 68839 0
Email 68839 0
[email protected]
Contact person for scientific queries
Name 68840 0
Dr Michael Samarinas
Address 68840 0
Urologist, Urology Department of University of Thessaly
Viopolis Mezourlo
41100
Larisa
Country 68840 0
Greece
Phone 68840 0
+306946006798
Fax 68840 0
Email 68840 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.