The Female Microbiome in Patients Undergoing Bladder Instillation Therapy
- Conditions
- Interstitial CystitisBladder Pain SyndromeMicrobial Colonization
- Interventions
- Registration Number
- NCT05414305
- Lead Sponsor
- Walter Reed National Military Medical Center
- Brief 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.
- Detailed Description
This study uses samples collected under an interventional study and consented for use in future research - this study is use of those samples under the future research provision, and this study was deemed to meet exempt category 4.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
- Patients who previously or will be undergoing bladder instillation therapy for treatment of IC/BPS and whom had or will have urine/vaginal specimens collected at the beginning and between 4-6th instillations.
- Patients not meeting inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Heparin & Alkalinized Lidocaine Bladder Instillation Heparin & Alkalinized Lidocaine Bladder Instillation Six weekly bladder instillations, each instillation consisting of 40,000 IU Heparin, 200mg lidocaine, 2ml 8.4% sodium bicarbonate, sterile water for a total volume 50 milliliters (mL).
- Primary Outcome Measures
Name Time Method Change of the female microbiome as measured by bacterial ribosomal RNA sequencing in patients with BPS/IC at baseline and during bladder instillation therapy Baseline, 4-6 weeks
- Secondary Outcome Measures
Name Time Method Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and Female Sexual Function Index (pain) questionnaire scores Baseline, 4-6 weeks Total score 0-6, with higher scores indicating worse symptoms
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and O'Leary-Sant questionnaire scores Baseline, 4-6 weeks Consists of O'Leary-Sant Symptom and Problem Index. Total score 0-36, with higher scores indicating worse symptoms
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and Female Sexual Distress-Revised Inventory questionnaire scores Baseline, 4-6 weeks FSDS-R evaluates distress associated with inadequate/impaired sexual function. Total score 0-52, with higher scores indicating worse symptoms
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and Short Form 12 questionnaire scores Baseline, 4-6 weeks SF-12 is a general health questionnaire that evaluates quality of life measures, divided into mental and physical component scores. Higher scores associated with better symptoms.
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and Visual Analog Scale questionnaire scores Baseline, 4-6 weeks Scale of 0-10 (0= no pain, 10 = worst pain)
Characterization of bacterial species present as measured by bacterial ribosomal RNA sequencing in the vaginal and urinary microbiome Baseline, 4-6 weeks Characterization of bacterial species diversity as measured by bacterial ribosomal RNA sequencing in the vaginal and urinary microbiome Baseline, 4-6 weeks
Trial Locations
- Locations (1)
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States