Prolonged catheterization in neurogenic bladder patients is a high risk of developing CAUTI, which causes many sequelae, including frequent recurrences, urosepsis, renal damage, and many complications caused by constant or repetitive antimicrobial use, as well as considerable economic and public health burdens. Currently, the prevention of CAUTI in neurogenic bladder patients, especially nutraceuticals, is not well elucidated and has controversial results. Proanthocyanidins (PACs), active comp
Conditions
Interventions
Cranberry herbal medicine 36 PACs OD in the morning and placebo in the evening
,Cranberry herbal medicine 36 PACs bid in the morning and in the evening,Identical placebo intervention crafted in the
Cranberry herbal medicine 36 PACs,Cranberry herbal medicine 72 PACs,Placebo
Sponsors
The Distinguished Research Professor Grant from the National Research Council of Thailand
Soho Flordis International, Switzerland
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged above 20 years old who were diagnosed as neurogenic; bladder determined by urodynamic study 2. Long-term indwelling urethral catheter > 30 days 3. Not a candidate for any surgical options or other treatment in the next 1 year 4. Ability to consent
Exclusion criteria
Exclusion criteria: 1. Patient who is allergic to cranberry-containing products 2. Patient who has severe cardiovascular disease 3. Patient with CKD-Epi eGFR < 30 mL/min 4. Patient who need to restrict fluid intake due to any medical conditions, including nephrological, cardiovascular, endocrinological, and liver disease. 5. Patient with nephrolithiasis 6. Patient who takes warfarin drug or have bleeding/coagulating problem; 7. Patient who has received antibiotic or intervention in the last 90 days for any medical/surgical reasons; 8. Patient who takes chemotherapy or immunosuppressant drug 9. Patient who retains antiseptic catheter; 10. Patient who needs to perform daily bladder irrigation or use other non-antibiotic prophylaxis with UroVaxom, StroVac, Angocin, D-Mannose; 11. Patient with GI. absorption disease 12. Patient who needs specific care or is not well-conscious
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of CAUTIs and hospitalization due to UTIs at 3 months after the end of the intervention general data, vital signs, urinalysis, urine culture | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine microbiota Every start new crossover arm and the end of each arm Metagenomic analysis, Urine Microbiome Extraction and 16s rRNA V3-V4 Sequencing,Urine metabolomics At the end of each arm ultra-performance liquid chromatography-electrospray ionization/quadrupole-time-of-flight (UPLC-ESI-QTOF) mass spectrometry (M.S.),Stool microbiota Every start new crossover arm and the end of each arm Metagenomic analysis, Urine Microbiome Extraction and 16s rRNA V3-V4 Sequencing,Stool metabolomics At the end of each arm ultra-performance liquid chromatography-electrospray ionization/quadrupole-time-of-flight (UPLC-ESI-QTOF) mass spectrometry (M.S.),Urine culture Every start new crossover arm and the end of each arm Urine culture for aerobic bacteria | — |
Countries
Thailand
Contacts
Public ContactThiraphat Saengmearnuparp
Chiangmai University
Outcome results
None listed