Considerations For Studies In Infectious Diseases Of The Genitourinary System

An Area of Significant Unmet Medical Need

Infectious diseases of the genitourinary system compromise quality of life for many women and can lead to serious conditions including pelvic inflammatory disease, infertility and cervical cancer. Women commonly experience genitourinary system infections:

• Bacterial vaginosis has an estimated prevalence of 21.2 million women aged 14-49
• Approximately one-third of women require antibiotic treatment for a urinary tract infection (UTI) by age 24, and half of women experience at least one UTI in their lifetime
• The Centers for Disease Control estimates that there are approximately 20 million new cases of sexually transmitted infections in the United States each year
• Recurrent genitourinary system infections are common

There is a substantial need for novel therapeutics for infectious diseases of the  genitourinary system. A variety of bacterial and viral pathogens, fungi and protozoan may cause infections of the reproductive system. Multi-drug resistant bacterial and protozoan STIs and HIV are significant global issues. In the treatment of UTIs, antimicrobial resistance is a challenge. Additionally, existing antivirals are not  recommended for human papillomavirus (HPV) infections; therapeutics are primarily  ablative or immunomodulatory. Clinical research is necessary to offer alternative treatment options and improve health outcomes in patients experiencing genitourinary system infections.