Serenoa repens, cucurbita pepo, lycopene and selenium as an adjunct to the treatment of chronic bacterial prostatitis with antibiotics

ISRCTN	ISRCTN10248199
DOI	https://doi.org/10.1186/ISRCTN10248199
Secondary identifying numbers	SRCLS-CT-2016

Submission date: 04/10/2017
Registration date: 05/10/2017
Last edited: 05/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic bacterial prostatitis is a bacterial infection of the prostate (a small gland located directly below the bladder in men). The aim of this study is to assess whether a capsule containing serenoa repens, cucurbita pepo, lycopene and selenium, used alongside antibiotics, can relieve the symptoms of chronic bacterial prostatitis and prevent reinfection.

Who can participate?
Men with chronic bacterial prostatitis

What does the study involve?
Participants are randomly allocated to one of two groups. Both groups receive antibiotic treatment for 15 days as a part of the regular treatment of chronic bacterial prostatitis. One group receives 6 months of treatment with one capsule per day of the study supplement (serenoa repens, cucurbita pepo, lycopene and selenium), while the other group receives one capsule per day for the same time period containing corn oil (placebo). The two groups complete symptom questionnaires and undergo urine flow tests and ultrasound scans at the start of the study and 1, 3, 6 and 12 months later.

What are the possible benefits and risks of participating?
The benefits include relief of the patients from chronic prostatitis symptoms and the improvement of their quality of life. There are no risks involved in participating in the study.

Where is the study run from?
Tzaneio Prefecture General Hospital (Greece)

When is the study starting and how long is it expected to run for?
September 2016 to June 2019

Who is funding the study?
Synapse Hellenic Pharmaceuticals & Services (Greece)

Who is the main contact?
1. Benjamin Polatidis (public)
2. Konstantinos Stamatiou (scientific)

Contact information

Mr Benjamin Polatidis
Public

Egnatias 117
Thessaloniki
54635
Greece

Mr Konstantinos Stamatiou
Scientific

Leoforos Afentouli ke Zanni
Pireas, Greece
185 36
Greece

Study information

Study design	Single-centre double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Serenoa repens, cucurbita pepo, lycopene and selenium as an adjunct to the treatment of chronic bacterial prostatitis with antibiotics: a placebo-controlled, double-blind, randomized clinical trial
Study objectives	The study hypothesis is that: 1. During the 2nd and the 3rd patients' visits there will be a statistically significant difference in the overall NIH-CPSI Questionnaire Score favouring the Group A (serenoa repens, cucurbita pepo, lycopene and selenium group) in comparison with Group B (placebo - corn oil group) 2. In all four visits (1, 3, 6 and 12 months), there will be a statistically significant difference in the IPSS Questionnaire Score favouring the Group A (serenoa repens, cucurbita pepo, lycopene and selenium group) in comparison with Group B (placebo - corn oil group), when comparing the subgroup of patients rated as moderate symptoms during initial visit (Initial IPSS : 8-19) 3. After 12 months, there will be lower rates of bacterial reinfection symptoms in Group A (serenoa repens, lycopene and selenium) in comparison with Group B (placebo group)
Ethics approval(s)	Institutional Review Board of Tzaneio Prefecture General Hospital, 13/12/2016
Health condition(s) or problem(s) studied	Chronic bacterial prostatitis and lower urinary tract symptom (LUTS)
Intervention	Participants are randomised into two groups (block randomisation, computer generated algorithm). Both groups receive antibiotic treatment for 15 days as a part of their regular treatment of chronic bacterial prostatitis. One group will receive 6 months of treatment with one capsule per day of the product (Serenoa Repens, Cucurbita Pepo, Lycopene & Selenium), while the other group will receive one capsule per day for the same time period containing corn oil (placebo). The study will compare the groups' scores in the two basic questionnaires National Institute of Healths' Chronic Prostatitis Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS), as well as changes in the clinical measurements Qmax, residual volume and prostate volume observed 1, 3, 6 and 12 months after the initial visit.
Intervention type	Supplement
Primary outcome measure	1. Prostatitis symptoms assessed using the National Institute of Health's Chronic Prostatitis Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS) at baseline, 1, 3, 6 and 12 months 2. Qmax measured using specific uroflowmetry techniques at baseline, 3, 6 and 12 months 3. Residual volume after urination and prostate volume measured by the urologist using ultrasound at baseline, 3, 6 and 12 months
Secondary outcome measures	Bacterial reinfection, assessed using Meares - Stamey Test and microbiological testing at baseline, 3, 6 and 12 months
Overall study start date	01/09/2016
Completion date	30/06/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	128
Key inclusion criteria	Adult patients with chronic bacterial prostatitis
Key exclusion criteria	1. Patients who are immediately diagnosed during their visit with acute bacterial prostatitis (NIH Category I) 2. Patients who receive treatment with an a-blocker (Terazosin, Doxazosin, Tamsulosin, Alfuzosin) 3. Patients who have been under treatment with antibiotics through the last 6 months 4. Patients who are under treatment with immunosuppressant drugs 5. Patients who are under treatment with drugs containing cortisone 6. Patents who are allergic to corn or cucurbita pepo 7. Patents who suffer from diabetes mellitus 8. Patients who had a history of urethral stricture or neurogenic bladder
Date of first enrolment	01/11/2017
Date of final enrolment	31/12/2017

Locations

Countries of recruitment

Greece

Study participating centre

Tzaneio Prefecture General Hospital

Leoforos Afentouli ke Zanni
Pireas
18536
Greece

Sponsor information

Synapse Hellenic Pharmaceuticals & Services
Industry

Egnatias 117
Thessaloniki
54635
Greece

Phone	+30 (0)2310217876
Email	info@synapse.com.gr
Website	www.synapse.com.gr
"ROR"	https://ror.org/01vx59p26

Funders

Funder type

Industry

Synapse Hellenic Pharmaceuticals & Services

No information available

Results and Publications

Intention to publish date	01/09/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal by September 2019.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Theodosios Theodosiou from StatNous, the company that will take over the whole statistical processing of the data (theodosiou@statnous.com). The data is expected to become available 3 months after the last patients visit. August 2019 is an approximate time expected. Consent from participants is obtained through the ICF form. No specific criteria have been set on who would be given access to the data, but after the work is published the data will be shared to anyone seriously interested upon request.