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Bladder Instillation Therapy for Interstitial Cystitis

Phase 2

Waitlist Available

Led By Eva K Welch, MD MS

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4-6 weeks

Awards & highlights

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.

Eligible Conditions

Microbial Colonization
Interstitial Cystitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4-6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4-6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of the female microbiome as measured by bacterial ribosomal RNA sequencing in patients with BPS/IC at baseline and during bladder instillation therapy

Secondary outcome measures

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

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Heparin & Alkalinized Lidocaine Bladder InstillationExperimental Treatment1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Heparin & Alkalinized Lidocaine Bladder Instillation

2020

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor

137 Previous Clinical Trials

34,468 Total Patients Enrolled

1 Trials studying Interstitial Cystitis

58 Patients Enrolled for Interstitial Cystitis

US Army Medical Research Institute of Infectious DiseasesFED

13 Previous Clinical Trials

1,359 Total Patients Enrolled

Eva K Welch, MD MSPrincipal InvestigatorWalter Reed National Military Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any worrisome side effects that come with this treatment plan?

"This is a Phase 2 trial, which means that while there is some evidence supporting the safety of this treatment, there is no data to suggest that it is effective. Our team at Power rates this as a 2."

Answered by AI

Are we still enrolling people for this research project?

"No, this study is not recruiting patients right now. The listing on clinicaltrials.gov shows that the trial was posted on October 1st 2020 and edited June 24th 2022. Although this particular research project isn't actively looking for subjects, there are 845 other trials that are presently enrolling volunteers."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Assessment of the Lower Urinary Tract Microbiota During Symptom Flare in Women with Urologic Chronic Pelvic Pain Syndrome: A MAPP Network Study

Nickel, J. Curtis, Alisa Stephens, J. Richard Landis, Chris Mullins, Adrie van Bokhoven, M. Scott Lucia, Garth D. Ehrlich, and MAPP Research Network. 2016. “Assessment of the Lower Urinary Tract Microbiota During Symptom Flare in Women with Urologic Chronic Pelvic Pain Syndrome: A MAPP Network Study”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2015.09.075.

Journal of Clinical MicrobiologyJournal

Evidence of Uncultivated Bacteria in the Adult Female Bladder

Wolfe, Alan J., Evelyn Toh, Noriko Shibata, Ruichen Rong, Kimberly Kenton, MaryPat FitzGerald, Elizabeth R. Mueller, et al.. 2012. “Evidence of Uncultivated Bacteria in the Adult Female Bladder”. Journal of Clinical Microbiology. American Society for Microbiology. doi:10.1128/jcm.05852-11.

Obstetrics & GynecologyJournal

Urinary Microbiome and Cytokine Levels in Women with Interstitial Cystitis

Abernethy, Melinda G., Amy Rosenfeld, James R. White, Margaret G. Mueller, Christina Lewicky-Gaupp, and Kimberly Kenton. 2017. “Urinary Microbiome and Cytokine Levels in Women with Interstitial Cystitis”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000001892.

American Journal of Obstetrics and GynecologyJournal