Cystitis Urological and Genital Diseases Cystitis
Conditions
Interventions
All the patients meeting the inclusion criteria, who signed the informed consent form to participate in the clinical trial, are randomized to one of three arms ( A, B or C) to receive a three month pr
Sponsors
PharmaMol SRL
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with a history of recurrent cystitis, defined as: 1.1. Participants must have two or more episodes of UTI in the last 6 months or 3-6 in the last 12 months 1.2. Participants much have had an UTI that was documented by urine culture 2. Experienced episodes at least by one urinary symptom and/or positive urinary nitrate test or leukocyturia
Exclusion criteria
Exclusion criteria: 1. Unable to provide informed consent 2. Pregnancy or lactation 3. Abnormalities of the upper urinary tract, including the presence of urinary stones 4. Patients with a permanent urinary catheter 5. Complete urinary incontinence 6. Patients with stage 5 chronic kidney disease (GFR <15 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic cystitis recurrence is measured through clinical evaluation and patient interviews at baseline, 90, 150/180 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of uropathogens is assessed using microbiological evaluation of urine sample, vaginal swab and a vaginal smear slide at baseline, 90 and 180 days. | — |
Countries
Italy
Outcome results
None listed