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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

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

Primary outcome measures

--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 outcome measures

Healthcare encounters

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal care bundleExperimental Treatment8 Interventions

Components of multimodal care bundle MD Evaluation On site pelvic floor physical therapy Behavioral health consult with appropriate psychiatric referrals/treatments Central sensitization/neurogenic pain: Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 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) Microbiome: Methenamine Vaginal estrogen At least once within 12 weeks of initial visit: Operative cystoscopy Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jocelyn FitzgeraldLead Sponsor

Jocelyn J Fitzgerald, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Multimodal Bundle Drugs (Multimodal Bundle Drugs) Clinical Trial Eligibility Overview. Trial Name: NCT05658874 — Phase 3

Interstitial Cystitis Research Study Groups: Usual care, Multimodal care bundle

Interstitial Cystitis Clinical Trial 2023: Multimodal Bundle Drugs Highlights & Side Effects. Trial Name: NCT05658874 — Phase 3

Multimodal Bundle Drugs (Multimodal Bundle Drugs) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05658874 — Phase 3

Frequently Asked Questions

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

Are seniors authorized to participate in this experiment?

"Participants in this trial must be of legal age or below their centenarian years."

Answered by AI

Are there any open slots in this experiment that participants may apply for?

"According to the details on clinicaltrials.gov, this medical endeavour is currently enrolling participants. It was first advertised on December 1st 2022 and its entry updated a fortnight later."

Answered by AI

To what degree is Multimodal care bundle a risk to patient welfare?

"Our team gave the safety of this multimodal care bundle a 3 due to existing evidence in favor of its efficacy and plentiful data affirming its security."

Answered by AI

How many participants are being admitted to this clinical research?

"Affirmative. As per information from clinicaltrials.gov, this medical trial is actively looking for recruitments and was initially posted on December 1st 2022 before being revised recently on the 16th of December 2022. 80 volunteers are desired at a single site."

Answered by AI

Who is eligible to register for this research project?

"This medical trial seeks to recruit 80 individuals with interstitial cystitis aged between 18 and 99. To be eligible, female candidates must score 6 points or higher on the O'Leary Sant Questionnaire as well as meet the age criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

Jocelyn Fitzgerald 2022. "A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05658874.

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