Plain English Summary
Background and study aims
Lower urinary tract symptoms can greatly reduce the quality of life in men and cause issues with urinating. They can be a sign of a benign prostatic hyperplasic (BPH) or an enlarged prostate. Even today, the exact reasons underlying the development and progression of LUTS / BPH have not been fully understood. Recent studies have shown that chronic inflammation (swelling) represents a crucial part in BPH, probably determining the hyperplasia (enlargement) of prostate cells. The inflammatory cells in fact, produce growth factors such as VEGF or TGF- β , which can support the fibromuscular growth in BPH. This is treated by using medication that block the growth such as alpha-blockers and 5-alpha reductase inhibitors or combination therapy have been used to relief symptoms and to prevent complications. Other studies have demonstrated the significant benefits of the combination therapy if compared with individual single therapies. However, despite the improvement in symptoms, side effects (erectile dysfunction, ejaculatory disorders, loss of libido) may limit adherence (sticking to) to treatment. For these reasons, some phytotherapics (using herbs for treatment), like the lipid extract (LE) of Serenoa repens (SeR) , selenium (Se) and lycopene (Ly) are currently used with the aim of improving symptoms and to limit the possible adverse effects. The aim of this study is to evaluate the efficacy and tolerability of a combination therapy of phytotherapies versus the single therapies in patients with LUTS/BPH.
Who can participate?
Adult men aged between 55 to 80 years old who have LUTS/BPH
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive Ser 320 mg, Ly and Se ( Profluss ®) 1 tablet per day for 1 year. Those in the second group receive tamsulosin 0.4 mg 1 tablet a day for 1 year. Those in the last group receive Ser 320 mg , Ly and Se ( Profluss ®) 1 tablet per day for 1 year + tamsulosin 0.4 mg 1 tablet per day for 1 year. Participants are assessed for IPSS, IPSS quality of life, IIEF-5, Qmax, post-void residual and ejaculation.
What are the possible benefits and risks of participating?
Participants may benefit from a reduction of IPSS and PVR and increase in Qmax and quality of life. Risks would
Where is the study run from?
Via Santa Sofia 78 (Italy)
When is the study starting and how long is it expected to run for?
March 2011 to March 2012
Who is funding the study?
Konpharma (Italy)
Who is the main contact?
Professor Giuseppe Morgia
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
618/12
Study information
Scientific title
Serenoa repens, lycopene and selenium vs. tamsulosin for the treatment of (LUTS)/ (BPH): An Italian multicenter comparative randomized study between single or combination therapy
Acronym
PROCOMB
Study hypothesis
To evaluate the efficacy and tolerability of the combination therapy between SeR, Ly and Se(Profluss ®) + tamsulosin versus the individual monotherapies with Ser, Ly and Se (Profluss ®) or tamsulosin in patients with LUTS/BPH.
Ethics approval
Polyclinic Hospital, University of Catania, 09 Oct 2011, ref: Identification Number 618
Study design
Randomized double-blinded multicenter study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Benign prostatic hyperplasia (BPH) / lower urinary tract symptoms (LUTS)
Intervention
Participants were randomized with a 1:1:1 ratio into three treatment arms each consisting of 75 patients: group A (Ser 320 mg, Ly and Se ( Profluss ®) 1 tablet per day for 1 year), group B (tamsulosin 0.4 mg 1 tablet a day for 1 year), group C (Ser 320 mg , Ly and Se ( Profluss ®) 1 tablet per day for 1 year + tamsulosin 0.4 mg 1 tablet per day for 1 year.
Intervention type
Drug
Phase
Not Applicable
Drug names
Serenoa repens, lycopene and selenium, tamsulosin
Primary outcome measure
Reduction of IPSS (≥ 3 points from baseline), a percentage reduction of IPSS (IPSS%) ≥ 25%, increase of Qmax (≥ 30% from the baseline) and the reduction of PVR in patients treated with SeR, Ly and Se (Profluss ®) + tamsulosin compared to those treated with SeR, Ly and Se (Profluss®) or tamsulosin monotherapies after 1 year
Secondary outcome measures
Secondary endpoints of the study were considered the change in erectile function (assessed by the International Index of Erectile Function-5 questionnaire), prostate volume, serum PSA and QoL at 1 year
Overall trial start date
01/03/2011
Overall trial end date
01/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 55 and 80 years old
2. Digital rectal examination negative for prostate cancer
3. Prostate-specific antigen (PSA) ≥ 4 ng / ml, International Prostate Symptom Score (IPSS) ≥ 12, prostate volume ≤ 60 cc (assessed by suprapubic ultrasound), Qmax ≤ 15 ml / s, post -void residual urine <150 ml.
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
225
Participant exclusion criteria
1. Prostate cancer, previous bladder cancer, diabetes mellitus, neurogenic disorders, severe liver disease, history of orthostatic hypotension or syncope, symptomatic urinary tract infection
2.Anti-androgens, antidepressants (neuroleptics, anticholinergics) therapy, recent treatment with an α blocker (within 1 month) or phytotherapy including saw palmetto extract (within 3 months), previous medical therapy with 5-ARI or surgical treatment for LUTS/BPH
3. Patients with catheter or with an episode of acute retention of urine in the last 4 weeks.
Recruitment start date
01/03/2011
Recruitment end date
01/03/2012
Locations
Countries of recruitment
Italy
Trial participating centre
Via Santa Sofia 78
Catania
95100
Italy
Funders
Funder type
Industry
Funder name
Konpharma (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25154739
Publication citations
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Results
Morgia G, Russo GI, Voce S, Palmieri F, Gentile M, Giannantoni A, Blefari F, Carini M, Minervini A, Ginepri A, Salvia G, Vespasiani G, Santelli G, Cimino S, Allegro R, Collura Z, Fragalà E, Arnone S, Pareo RM, Serenoa Repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial)., Prostate, 2014, doi: 10.1002/pros.22866.