Recurrent Urinary Tract Infections in Women
Conditions
Keywords
Phase 2, Vaccine, Urinary Tract Infection, Vaginal Mucosal
Brief summary
The purpose of this study is determine whether a vaginal mucosal vaccine given to women with a history of recurrent urinary tract infections can reduce the number of infections occurring in a six-month study period, as compared to placebo treatment.
Detailed description
Recurrent urinary tract infections (UTIs) affect approximately 10% of women in the United States. Since antibiotic prophylaxis is not always effective, alternate treatments need to be developed. One such treatment would be immunization with a vaccine containing bacteria known to cause these infections. The objective of the study is to immunize susceptible women with inactivated bacteria contained in a vaginal suppository and to monitor the rates of reinfection compared to a group of women treated with placebo suppositories. Each group of patients will receive a total of six suppositories in the first four-months of the six-month study during which all UTIs and side effects will be recorded. The infection rates between vaccine- and placebo-treated women will be statistically analyzed to determine vaccine efficacy.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Three or more urinary tract infections in the previous year
Exclusion criteria
* Neurogenic bladder * Interstitial cystitis * Urinary diversion * Kidney stones * Indwelling catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of re-infection over the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Infection-free status at completion of study | — |
Countries
United States