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Multimodal Bundle Drugs

Multimodal Bundled Care for Chronic Pelvic Pain

Phase 3

Recruiting

Led By Jocelyn J Fitzgerald, MD

Research Sponsored by Jocelyn Fitzgerald

Eligibility Criteria Checklist

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

Must have

Diagnosis of Interstitial Cystitis/Painful Bladder Syndrome, scoring 6 points or higher on O'Leary Sant Questionnaire

Be older than 18 years old

Must not have

Active pelvic or bladder infection within past 2 weeks

Meets criteria for diagnostic laparoscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing different treatment patterns to see if they help people with chronic bladder pain. It'll involve 5 visits, physical & behavioral therapy, and measure the pain before & after.

Who is the study for?

This trial is for women over 18 with chronic bladder pain diagnosed as Interstitial Cystitis/Painful Bladder Syndrome, scoring at least 6 on a specific questionnaire. It's not for those with recent infections, medication contraindications, language barriers, certain diagnostic criteria or recent pelvic procedures.

What is being tested?

The study compares two treatments: a 'bundled-care' approach including drugs, cystoscopy, therapy and physical therapy versus usual care. Participants will have multiple visits to assess symptoms using questionnaires and undergo at least one procedural visit.

What are the potential side effects?

Potential side effects may include discomfort from cystoscopy, reactions to medications like Methenamine or Amitriptyline/Gabapentin (such as dry mouth or dizziness), hormonal changes due to vaginal estrogen and soreness from physical therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Interstitial Cystitis and my pain score is 6 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a pelvic or bladder infection in the last 2 weeks.

Select...

I am eligible for a diagnostic laparoscopy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

--O'Leary Sant Questionnaire (OLS), comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), at 12 weeks from baseline MCID: 4 points for ICSI Change in O'Leary Sant Questionnaire Scores >4 points

Secondary study objectives

Healthcare encounters

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal care bundleExperimental Treatment8 Interventions

Components of multimodal care bundle 1. MD Evaluation 2. On site pelvic floor physical therapy 3. Behavioral health consult with appropriate psychiatric referrals/treatments 4. Central sensitization/neurogenic pain: Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS: Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc)

Group II: Usual careActive Control1 Intervention

IC/PBS treatments as directed by Urogynecology specialist

0 / 3Eligibility criteria met