Treatment for Bladder Pain Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Walter Reed National Military Medical Center, Bethesda, MD
Bladder Pain Syndrome+6 More
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial looks at the difference in the bladder and vaginal microbiome of women with IC/BPS during a flare versus nonflare. The study found that there was no significant difference 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. This trial is testing a new treatment for Bladder Pain Syndrome. All patients in the trial will receive the new treatment, not a placebo.

Eligible Conditions

  • Bladder Pain Syndrome
  • Interstitial Cystitis
  • Microbial Colonization

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline, 4-6 weeks

Baseline, 4-6 weeks
Change of the female microbiome as measured by bacterial ribosomal RNA sequencing in patients with BPS/IC at baseline and during bladder instillation therapy
Characterization of bacterial species diversity as measured by bacterial ribosomal RNA sequencing in the vaginal and urinary microbiome
Characterization of bacterial species present as measured by bacterial ribosomal RNA sequencing in the vaginal and urinary microbiome
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and Female Sexual Distress-Revised Inventory questionnaire scores
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and Female Sexual Function Index (pain) questionnaire scores
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and O'Leary-Sant questionnaire scores
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and Short Form 12 questionnaire scores
Correlation of female microbiome as measured by bacterial ribosomal RNA sequencing and Visual Analog Scale questionnaire scores

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

0 Treatment Group

29 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 2

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4-6 weeks
Closest Location: Walter Reed National Military Medical Center · Bethesda, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
2010First Recorded Clinical Trial
2 TrialsResearching Bladder Pain Syndrome
184 CompletedClinical Trials

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
124 Previous Clinical Trials
35,565 Total Patients Enrolled
1 Trials studying Bladder Pain Syndrome
58 Patients Enrolled for Bladder Pain Syndrome
US Army Medical Research Institute of Infectious DiseasesFED
13 Previous Clinical Trials
1,859 Total Patients Enrolled
Eva K Welch, MD MSPrincipal InvestigatorWalter Reed National Military Medical Center

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References