Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women
Prophylactic Use of Cranberries in Recurrent Bacterial Cystitis in Women
To investigate if oral administration of 240mg PAC of cranberries can reduce the number of
 episodes of acute bacterial cystitis and improve general QoL in women with recurrent
 bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the
 adverse effect profile of the drug will be reported.

 Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from
 the outpatient population who present to their family physician or specialist with
 symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will
 be divided in groups according to their age. Urinary culture, vaginal and rectal swab will be
 taken from all the patients. Antibiotic treatment will be prescribed (using the drug of
 choice according to the urine culture and the treating physician choice). Subsequently, they
 will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean
 240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment
 and after a negative urinary culture patients will continue to receive per os, daily, one
 capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively.

 Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine collection,
 vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12
 visits.

 Participants will be asked about medication usage, any side effects they may be experiencing
 at each study visit. If participants develop a UTI at any time during the study, they will be
 asked to visit the study site within 24 hours.
Inclusion Criteria:

 -  Negative urine culture

 -  At least 3 UTI's within 12 months prior to study entry

 Exclusion Criteria:

 -  Anatomic abnormalities of the urinary tract

 -  Use of investigational drugs within 30 days prior to study entry

 -  Current use of warfarin

 -  Allergy or intolerance of cranberry products

 -  > 50 ml of residual urine (measured by US)

 -  Use of indwelling catheter

 -  uncontrolled diabetes

 -  creatinine > 250 mmol/l,

 -  Symptomatic vaginitis

 -  Pregnant or breastfeeding