Sprite study

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN73316039
• Date of registration: 22/05/2015
• Prospective Registration: Yes
• Primary sponsor: Konpharma SRL
• Public title: Sprite study
• 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
• Date of first enrolment: 01/06/2015
• Target sample size: 600
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN73316039
• Study type: Interventional
• Study design: Randomised non-inferiority multicentre study (Treatment)
• Phase: Phase III/IV

Countries of recruitment

Italy

Contacts

• Name: Giorgio Ivan Russo

• Name: Giuseppe Morgia

Key inclusion & exclusion criteria

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

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
a 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


Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS)
Urological and Genital Diseases
Hyperplasia of prostate

Intervention(s)

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

Primary Outcome(s)

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(s)

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)

Secondary ID(s)

39/15

Source(s) of Monetary Support

Konpharma SRL (Italy)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/01/2017