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NCT05414305 · ClinicalTrials.gov registry record · Phase 2
The Female Microbiome in Patients Undergoing Bladder Instillation Therapy
A Phase 2 study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT05414305 is a Phase 2 study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 29 participants.
The verdict
NCT05414305, a Phase 2 study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study 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.
Interventions
- DRUG Heparin & Alkalinized Lidocaine Bladder Instillation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05414305
The ClinicalTrials.gov registry entry for NCT05414305 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Heparin & Alkalinized Lidocaine Bladder Instillation is the first listed.
NCT05414305 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05414305 about?
NCT05414305 is a clinical study titled "The Female Microbiome in Patients Undergoing Bladder Instillation Therapy". 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) s...
What is the current status of trial NCT05414305?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2020-10-01. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT05414305?
The interventions under investigation include: Heparin & Alkalinized Lidocaine Bladder Instillation (DRUG).
Who is sponsoring clinical trial NCT05414305?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
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