Benign prostatic hyperplasia
Conditions
Interventions
Participants will be assigned to receive either cranberry tablets or placebo tablets for a duration of 12 months.
Sponsors
Teruo Inamoto
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients aged over 18 years with benign prostatic hyperplasia. 2.Patients with a prostate volume over 30 mL and a post-void residual urine volume under 100 mL, as assessed by transabdominal ultrasonography. 3.Patients who have provided written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1.Patients currently diagnosed with and undergoing treatment for UTI. 2.Patients with severe hepatic or renal dysfunction (Child Pugh C, eGFR under 30) 3.Patients receiving warfarin or sodium valproate. 4.Patients with hypersensitivity to cranberry. 5.Patients with severe food allergies 6.Patients undergoing treatment for urolithiasis 7.Patients with cognitive impairment or decline in ADL severe enough to make completion of a voiding diary difficult 8.Patients deemed unsuitable for participation by the principal investigator or sub investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of UTI during the 12-month observation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinalysis Urinary sediment examination Urine culture (bacterial species, colony count) Treatment adherence/compliance rate Voiding diary (mean voided volume per micturition, daytime urinary frequency, nocturnal urinary frequency, nocturnal urine volume, NPI [nocturnal polyuria index]) Occurrence of fever, urinary frequency, urgency, dysuria, and CVA tenderness IPSS, OABSS, QOL scores Incidence of UTI related hospitalization Bristol Stool Scale GSRS (Gastrointestinal Symptom Rating Scale) Adverse events (primarily gastrointestinal symptoms and occurrence of urolithiasis) | — |
Contacts
Public ContactWatanabe Kyohei
Hamamatsu University School of Medicine
Outcome results
None listed