Vaccine for Recurrent Urinary Tract Infections in Women
- Conditions
- Recurrent Urinary Tract Infections in Women
- Registration Number
- NCT00261248
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 75
- Three or more urinary tract infections in the previous year
- Neurogenic bladder
- Interstitial cystitis
- Urinary diversion
- Kidney stones
- Indwelling catheter
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of re-infection over the study
- Secondary Outcome Measures
Name Time Method Infection-free status at completion of study
Trial Locations
- Locations (1)
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States