The Female Microbiome in Patients Undergoing Bladder Instillation Therapy
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
The underlying pathophysiology for BPS/IC is currently an active area of research. There is
speculation that there may be alteration in the bladder and vaginal microbiome that
contributes to the symptomatology of BPS/IC, however existing literature is limited and
contradictory. Nickel et al (2015) studied the bladder microbiota in women with IC/BPS during
a flare versus nonflare. The study collected initial stream and midstream urine specimens and
detected overall, there was no significant differences in the species composition. However, a
greater prevalence of fungi (Candida and Saccharomyces) was seen in the flare group (15.7%)
versus the non-flare group (3.9%) midstream urine specimens. Pearce et al (2015) sought to
characterize the urinary microbiome via catheterized specimens from women with urgency
urinary incontinence, a condition that can present similarly as IC/BPS. The study found that
more than half of the patients were sequence positive, most commonly for Lactobacillus (45%)
or Gardnerella (17%), with 25% made up of various other bacteria. In contrast, Abernethy et
al (2017) showed via catheterized urine specimens from patients with IC/BPS that the urinary
microbiome is less diverse and less likely to contain Lactobacillus species. There have been
two recent studies investigating the female urinary microbiome in patients with IC/BPS.
Nickel et al (2019) found no differences in species composition between urine from patients
with IC/BPS versus controls. Meriwether et al (2019) reported similar findings, and
additionally found no differences when comparing the vaginal bacterial microbiome in patients
with IC/BPS versus controls. However, in evaluating the bladder microbiome, both studies
utilized uncatheterized urine specimens. Wolfe et al (2012) showed microbiome differences
between clean-catch and catheterized urine specimens, therefore vaginal contamination in both
studies cannot be ruled out.
Phase:
Phase 2
Details
Lead Sponsor:
Walter Reed National Military Medical Center
Collaborator:
US Army Medical Research Institute of Infectious Diseases