Documentation of Efficacy and Tolerability of the Preparation GRANU FINK® Prosta forte 500mg

Active, not recruiting

• Conditions: D29.1; Prostate

• Registration Number: DRKS00010729
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-22
• Study Completion: 2020-07-28
• Results First Posted: 2022-05-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

• BPS complaints for at least the past 3 months: (moderate) Symptoms of the lower urinary tract (LUTS), Benign prostatic enlargement (BPE), Bladder outlet obstruction (BOO)
• People who have legal capacity and who are mentally capable to understand and follow the instructions given by the staff of the study.
• written informed consent of the patient
• IPSS = 13 points

Exclusion Criteria

• contraindications according to the summary of product characteristics
• pharmaceutical or surgical treatment of BPS in the last 3 months
• manipulation of bladder and prostate in the last 3 months (cystoscopy, biopsy, operation)
• neurogenic or malignant disease
• recurring urinary retention
• recurring urinary tract infections
• conservative, recurrent macrohematuria that cannot be controlled
• concretions in the bladder
• dilatation of the upper urinary tract, limited kidney function or renal insufficiency due to bladder outlet obstruction
• patients using indwelling catheter or self-catheterization
• abnormal secondary sexual characteristics
• missing informed consent from the patient

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of symptoms in patients with BPS when treated with GRANUFINK® Prosta forte 500 mg, operationalised as a change in IPSS after 12 months of treatment compared to baseline.