Condition category
Urological and Genital Diseases
Date applied
06/11/2013
Date assigned
11/12/2013
Last edited
25/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Giuseppe Morgia

ORCID ID

Contact details

Via Santa Sofia 78
Catania
95100
Italy

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 measures

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

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

Sponsor information

Organisation

Konpharma (Italy)

Sponsor details

via Pietro Della Valle
1
Roma
00193
Italy

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25154739

Publication citations

  1. 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.

Additional files

Editorial Notes

25/05/2017: Plain English summary added.