Sprite study

Phase 3

Completed

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

• Registration Number: ISRCTN73316039
• Lead Sponsor: Konpharma SR

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29569389

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-22
• Study Completion: 2017-01-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 600

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> 2. IPSS quality of life (QoL) questionnaire<br> 3. Maximum urinary flow rate (Qmax uroflowmetry)<br> 4. International Index of Erectile Function (IIEF-5) score<br>

Secondary Outcome Measures

Name	Time	Method
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)