| ISRCTN | ISRCTN73316039 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73316039 |
| Secondary identifying numbers | 39/15 |
- Submission date
- 23/04/2015
- Registration date
- 22/05/2015
- Last edited
- 07/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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)
Contact information
Scientific
Via Santa Sofia 78
Catania
95100
Italy
 ORCID ID |
0000-0002-7224-7577 |
|---|
Public
Via Santa Sofia 78
Catania
95100
Italy
Study information
| Study design | Randomised non-inferiority multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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): the Sprite study |
| Study objectives | 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(s) | Polyclinic Hospital, University of Catania, 10/04/2015, ref: 39/2015 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | 1. Serenoa repens 320mg, selenium and lycopene (Profluss ®) 2. Tadalafil® 5mg |
| Primary outcome measure | 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 study start date | 01/05/2015 |
| Completion date | 31/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 600 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Italy
Study participating centres
Catania
78-95123
Italy
Florence
50121
Italy
Rome
00173
Italy
Perugia
06100
Italy
Novara
-
Italy
Sassari
07100
Italy
Milan
20154
Italy
Palermo
90123
Italy
Lucca
-
Italy
Avellino
83100
Italy
Ravenna
-
Italy
Lugo di Romagna
-
Italy
Prato
-
Italy
Rome
00153
Italy
Cuneo
Savigliano
12038
Italy
Fano Pesaro Urbino
61032
Italy
Ancona
-
Italy
Frascati
-
Italy
Rome
00186
Italy
Napoli
80131
Italy
Palermo
90127
Italy
Acireale
-
Italy
Reggio Calabria
-
Italy
Rome
-
Italy
Torino
-
Italy
Catania
95124
Italy
Palermo
90127
Italy
Rome
00171
Italy
Sponsor information
Industry
Via Pietro Della Valle 1
Rome
00193
Italy
"ROR" |
https://ror.org/052hty126 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists are planning to disseminate preliminary results in the form of an abstract in December 2017, and the full results in June 2018. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Giorgio Ivan Russo upon publication of the paper. Consent was obtained, all data are anonymous. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 06/11/2017 | 15/11/2017 | No | No | |
| Results article | results | 01/08/2018 | Yes | No |
Additional files
- ISRCTN73316039_BasicResults_06Nov17.pdf
- Uploaded 15/11/2017
Editorial Notes
07/01/2019: Publication reference added.
15/11/2017: The overall trial end date was changed from 15/11/2016 to 31/01/2017. The basic results of this trial have been uploaded as an additional file.
07/11/2017: IPD sharing statement added.
