Multimodal Bundled Care for Chronic Pelvic Pain

Recruiting in Palo Alto (17 mi)

Overseen byJocelyn J Fitzgerald, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Jocelyn Fitzgerald

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. The main questions the investigators are seeking to answer is if bladder pain improves before and after treatment using a painful bladder scale. The participant will have 5 visits to evaluate your symptoms with questionnaires, at least one procedural visit, and must participate in physical therapy and some kind of behavioral health therapy. This study will assess participant response to a bundled-care approach to chronic bladder pain both pre-and post intervention as well as compared to a group of participants receiving typical care.

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged 18 or older.

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

Exclusion Criteria

I have not had any pelvic floor procedures, including bladder treatments, in the last 4 weeks.

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

I am allergic or react badly to certain medications or treatments.

+3 more

Participant Groups

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.

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