Urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. The use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy of intravesical bacteriophage treatment to normalize urine culture compared to intravesical placebo or standard antibiotic treatment in a randomized controlled trial following a pilot phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
97
Intravescial instillation
Oral application
Sterile bacteriology media, with identical color as bacteriophage preparation
National Center of Urology
Tbilisi, Georgia
Normalisation of urine culture
Success of intravesical treatment, defined as normalization of urine culture (no evidence of bacteria, i.e. \<104 colony forming units/mL) after 7 days of bacteriophage, placebo, or antibiotic treatment
Time frame: 7 days after treatment
Urine culture
Time frame: Baseline and 7 days after treatment
Bladder diary
Assessment of number of voids, number of leakages, post void residual
Time frame: Baseline and 7 days after treatment
Pain diary
Visual analog scale (0 (no pain) to 10 (strongest possible pain))
Time frame: Baseline and 7 days after treatment
IPSS questionnaire
Time frame: Baseline and 7 days after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.