Condition category
Urological and Genital Diseases
Date applied
23/04/2015
Date assigned
22/05/2015
Last edited
01/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Benign prostatic hyperplasia (BPH) (prostate enlargement) and lower urinary tract symptoms (LUTS) are common conditions that affect older men. The prostate is a small gland found inside the pelvis of men between the penis and the bladder. If it becomes enlarged, it can put pressure on the bladder and interfere with urinating. More common symptoms of prostate enlargement include a frequent need to urinate, difficulty starting to urinate and problems in fully emptying the bladder. It is not known why some men’s prostate becomes enlarged, but it’s thought to be related to hormonal changes as a man gets older. Some studies have shown that chronic inflammation of the prostate can lead to enlargement of the prostate cells and development of BPH. There are some drug treatments available which help to block the inflammation of prostate cells and relieve symptoms of BPH. Also, there is some evidence that combining certain drugs can relieve symptoms of BPH better than standard single drug treatments. One treatment available for BPH is Tadalafil® tablets, which are said to help reduce symptoms of BPH and improve urine flow, but how well it works is still controversial. The aim of this study is to test a new combination drug called Profluss® to see if it works better at relieving the symptoms of BPH and LUTS than Tadalafil®.

Who can participate?
Men aged 50-75 with prostate enlargement.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given Profluss® tablets and take one a day for 6 months. Those in group 2 (control group) are given Tadalafil® tablets and take one a day for 6 months. At the start of the study, all participants complete questionnaires and have urine tests used to assess BPH, then again at 1, 3 and 6 months.

What are the possible benefits and risks of participating?
Participating in this study may help patients reduce symptoms of BPH and LUTS. There is a possible risk of side effects related to the prescribed drugs, however all risks are fully discussed with participants before the start of the trial.

Where is the study run from?
University of Catania, G. Rodolico Hospital (Universitaria Policlinico di Catania - POG Rodolico) and 27 other hospitals in Italy

When is the study starting and how long is it expected to run for?
May 2015 to November 2016

Who is funding the study?
Konpharma SRL (Italy)

Who is the main contact?
1. Prof G Morgia (scientific)
2. Dr GI Russo (public)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Giuseppe Morgia

ORCID ID

http://orcid.org/0000-0002-7224-7577

Contact details

Via Santa Sofia 78
Catania
95100
Italy

Type

Public

Additional contact

Dr Giorgio Ivan Russo

ORCID ID

Contact details

Via Santa Sofia 78
Catania
95100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39/15

Study information

Scientific title

Serenoa repens, lycopene and selenium vs. phosphodiesterase type 5 inhibitor (PDE5 inhibitor) for the treatment of lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH): sprite study

Acronym

Study hypothesis

To evaluate the efficacy and tolerability of the combination therapy Serenoa repens, selenium and lycopene (Profluss®) versus a PDE5 inhibitor (Tadalafil® 5 mg) for 6 months for the treatment of LUTS/BPH.

Ethics approval

Polyclinic Hospital, University of Catania, 10/04/2015, ref: 39/2015.

Study design

Randomised non-inferiority multicentre study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS)

Intervention

1. Group A Serenoa repens 320mg, selenium and lycopene (Profluss ®) 1 tablet per day for 6 months.
2. Group B Tadalafil® 5mg 1 tablet a day for 6 months

Intervention type

Drug

Phase

Phase III/IV

Drug names

1. Serenoa repens 320mg, selenium and lycopene (Profluss ®)
2. Tadalafil® 5mg

Primary outcome measures

1. Mean change of international prostate symptom score (IPSS) and peak flow in patients treated with Profluss® or Tadalafil® 5mg. The study is designed as non-inferiority study with a 95% power and an equivalence margin of 0.5 for IPSS and of 0.8 for the peak flow.
2. IPSS quality of life (QoL) questionnaire
3. Maximum urinary flow rate (Qmax uroflowmetry)
4. International Index of Erectile Function (IIEF-5) score

Secondary outcome measures

Mean changes of post-void residual (PVR) volume in patients treated with Profluss® or Tadalafil® 5 mg at enrollment (visit 0), one month (visit 1), at 3 months (visit 2), at 6 months (visit 3).

Overall trial start date

01/05/2015

Overall trial end date

15/11/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 50 and 75
2. Digital rectal examination negative for prostate cancer
3. Prostate specific antigen (PSA) <4ng/ml
4. IPSS ≥12
5. PVR <100 ml
6. Peak flow between 4 and 15ml/s

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

600

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. Antiandrogens, 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 5ARI, PDE-5i or surgical treatment for LUTS/BPH.
3. Patients with catheter or with an episode of acute retention of urine in the last 3 months

Recruitment start date

01/06/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Italy

Trial participating centre

University of Catania, G. Rodolico Hospital (Universitaria Policlinico di Catania - POG Rodolico)
Department of Urology (UOC di Urologia)
Catania
78-95123
Italy

Trial participating centre

University of Florence (Università degli Studi di Firenze)
Urology Clinic (Clinica Urologica)
Florence
50121
Italy

Trial participating centre

University of Rome Tor Vergata (Università Tor Vergata Roma)
Urology Clinic (Clinica Urologica)
Rome
00173
Italy

Trial participating centre

University of Perugia (Università degli Studi di Perugia)
Urology Clinic (Clinica Urologica)
Perugia
06100
Italy

Trial participating centre

University of Novara (Università degli Studi di Novara)
Urology Clinic (Clinica Urologica)
Novara
Italy

Trial participating centre

University of Sassari (Università degli Studi di Sassari)
Urology Clinic (Clinica Urologica)
Sassari
07100
Italy

Trial participating centre

AO Clinical Institutes of Improvement in Milan (AO Istituti Clinici di Perfezionamento di Milano)
Urology Service (Servizio Urologia)
Milan
20154
Italy

Trial participating centre

Buccheri La Ferla Hospital (Ospedale Buccheri La Ferla)
Urology Division (Divisione Urologia)
Palermo
90123
Italy

Trial participating centre

Civil Hospital Lucca (Ospedale Civile Lucca)
Urology Division (Divisione Urologia)
Lucca
Italy

Trial participating centre

Civil Hospital of Avellino (Ospedale civile di Avellino)
Urology division (Divisione Urologia)
Avellino
83100
Italy

Trial participating centre

Hospital of Ravenna (Ospedale di Ravenna)
Urology division (Divisione Urologia)
Ravenna
Italy

Trial participating centre

Hospital Dir UO Div Urologica OC Lugo
Urology Division (Divisione Urologia)
Lugo di Romagna
Italy

Trial participating centre

Urology of the New Hospital (Urologia del Nuovo Ospedale)
Urology division (Divisione Urologia)
Prato
Italy

Trial participating centre

Regina Margherita Hospital (Ospedale Nuovo Regina Margherita)
Urology Division (Divisione Urologia)
Rome
00153
Italy

Trial participating centre

Hospital SS Annunziata (Ospedale SS Annunziata)
Urology Division (Divisione Urologia) Cuneo
Savigliano
12038
Italy

Trial participating centre

Hospital Santa Croce (Presidio Ospedaliero Santa Croce)
Urology Division (Divisione Urologia)
Fano Pesaro Urbino
61032
Italy

Trial participating centre

United Hospitals of Ancona (Ospedali Riuniti di Ancona)
Urology Division (Divisione Urologia)
Ancona
Italy

Trial participating centre

Urology Hospital Frascati (Urologia Ospedale Frascati)
Urology Division (Divisione Urologia)
Frascati
Italy

Trial participating centre

Fatebenefratelli Hospital (Ospedale Fatebenefratelli)
Urology Division (Divisione Urologia)
Rome
00186
Italy

Trial participating centre

Cardarelli Hospital (Ospedale Cardarelli)
Urology Division (Divisione Urologia)
Napoli
80131
Italy

Trial participating centre

Palermo Civic Hospital (Ospedale Civico Palermo)
Urology Division (Divisione Urologia)
Palermo
90127
Italy

Trial participating centre

ASP Catania
Urology Division (Divisione Urologia)
Acireale
Italy

Trial participating centre

Hospital Riuniti (Ospedale Riuniti)
Urology (UOC Urologia)
Reggio Calabria
Italy

Trial participating centre

Daughters of St. Camillus (Figlie di San Camillo)
Urology Division (Divisione Urologia)
Rome
Italy

Trial participating centre

ASL di Collegno e Pinerolo Hospital (ASL di Collegno e Pinerolo)
Urology Division (Divisione Urologia)
Torino
Italy

Trial participating centre

Hospital Garibaldi (Ospedale Garibaldi)
Urology (UOC Urologia)
Catania
95124
Italy

Trial participating centre

Civic Hospital (Ospedale Civico)
Urology (UOC Urologia)
Palermo
90127
Italy

Trial participating centre

Nursing Home Fabia Mater (Casa di Cura Fabia Mater)
Urology Division (Divisione Urologia)
Rome
00171
Italy

Sponsor information

Organisation

Konpharma SRL

Sponsor details

Via Pietro Della Valle 1
Rome
00193
Italy

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Konpharma SRL (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are planning to disseminate preliminary results in the form of an abstract in December 2017, and the full results in June 2018.

Intention to publish date

01/06/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes