Multimodal Bundled Care for Chronic Pelvic Pain

Overseen By Judy Gruss, RN

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Jocelyn Fitzgerald

Disqualifiers: Active infection, Language barrier, Recent procedure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

26 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. It mentions that patients are not excluded for currently taking any medication on the treatment list.

What data supports the effectiveness of the multimodal bundled care treatment for chronic pelvic pain?

Research suggests that a multidisciplinary approach, which combines medical treatments with behavioral and physical therapies, improves outcomes like pain severity and general health more effectively than using medical or surgical treatments alone. ^{1 2 3 4 5}

Is multimodal bundled care for chronic pelvic pain safe for humans?

The available research suggests that a multidisciplinary approach to managing chronic pelvic pain, which includes various treatments like medication combinations and therapy, is generally safe and can reduce emergency visits and medication use, indicating a positive safety profile. ^{1 2 3 6 7}

How is the Multimodal Bundle Drugs treatment different from other treatments for chronic pelvic pain?

The Multimodal Bundle Drugs treatment is unique because it combines different classes of medications, which is often more effective than using a single drug. This approach is part of a broader, interdisciplinary strategy that addresses not just the physical symptoms but also the psychological and social factors contributing to chronic pelvic pain. ^{1 2 3 8 9}

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.

Research Team

Jocelyn J Fitzgerald, MD

Principal Investigator

University of Pittsburgh

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multimodal care bundle including MD evaluation, pelvic floor physical therapy, behavioral health consult, and various medications and procedures

12 weeks

5 visits (in-person), at least 1 procedural visit

Follow-up

Participants are monitored for safety and effectiveness after treatment using questionnaires and healthcare encounters

1 year

Treatment Details

Interventions

• Amitriptyline/Gabapentin
• Behavioral health consultation/therapy
• Bladder Instillation
• Methenamine
• Multimodal Bundle Drugs
• Operative Cystoscopy
• Pelvic floor physical therapy
• Usual Urogynecologic care
• Vaginal estrogen

Trial Overview 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.

Participant Groups

Group I: Multimodal care bundle Experimental Treatment 8 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 care Active Control 1 Intervention

IC/PBS treatments as directed by Urogynecology specialist

Who Is Running the Clinical Trial?

Jocelyn Fitzgerald

Lead Sponsor

Trials

1

Recruited

30+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Drug Combinations for Chronic Pelvic Pain: Protocol for a Systematic Review. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Hospital-associated Costs of Chronic Pelvic Pain in Canada: A Population-based Descriptive Study. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence-based management of chronic pelvic pain. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Chronic pelvic pain in an interdisciplinary setting: 1-year prospective cohort. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Widespread myofascial dysfunction and sensitisation in women with endometriosis-associated chronic pelvic pain: A cross-sectional study. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Impact of a Persistent Pelvic Pain Clinic: Emergency attendances following multidisciplinary management of persistent pelvic pain. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Creating a bundled care payment model for treatment of pelvic floor disorders: introducing value into urogynecology. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Centering as a model for group visits among women with chronic pelvic pain. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

The development and efficacy of an interdisciplinary chronic pelvic pain program. [2021]