D29.1
Conditions
Interventions
Group 1: In patients suffering from moderate lower urinary tract symptoms, who do not require surgical treatment and are being treated with GRANU FINK® Prosta forte 500 mg over a period of 24 months u
Sponsors
Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentages of patients with an improvement in the IPSS (International Prostate Symptom Score) of at least 3 and 5 score points after 12 months. 2. Change in lower urinary tract symptoms after 3, 6 and 24 months, measured in terms of the change in IPSS 3. Change in quality of life after 3, 6, 12, and 24 months, measured in terms of the change in the IPSS-related quality of life index (question regarding quality of life on the IPSS questionnaire) 4. Change in quality of life after 3 months measured in terms of the change in the aging males symptoms scale (AMS), subsequently further collection of data for the generation of hypothesis (6, 12 and 24 months) 5. Change in strength of the urinary stream after 3, 6, 12, and 24 months, measured in terms of the change in the score of question 5 of the IPSS 6. Change in micturition frequency at night after 3, 6, 12, and 24 months, measured in terms of the change in the score of question 7 of the IPSS 7. Change in the sexual quality of life after 3 months, measured in terms of the change in the score of questions 13 to 17 of the AMS, subsequently further collection of data for the generation of hypothesis (6, 12, and 24 months) 8. Examination of the tolerability of the preparation (recording adverse drug reactions) | — |
Countries
Germany
Contacts
Public ContactPaolo Fornara
Universitätsklinikum Halle, Klinik und Poliklinik für Urologie
Outcome results
None listed