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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combination of treatments can better alleviate chronic bladder pain compared to standard care. Participants with Interstitial Cystitis or Painful Bladder Syndrome will undergo medical evaluations, physical therapy, and behavioral health support. The trial will also test various medications, such as those for nerve pain and bladder spasms, and may include procedures like bladder instillations, where medicine is placed directly into the bladder. Women who have experienced painful bladder symptoms and meet a certain score on a common questionnaire may qualify to participate. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like amitriptyline and gabapentin are usually well-tolerated. These medications often treat nerve pain and sensitivity issues. While they can cause side effects like drowsiness or dizziness, serious problems are rare.

Bladder medications such as oxybutynin and mirabegron are also commonly used to help with bladder spasms and overactivity. Most people handle these drugs well, though some might experience dry mouth or constipation.

Methenamine is another medication used for urinary issues and is known for its safety, with few reported side effects.

Vaginal estrogen is generally safe for treating local symptoms in women, though it might rarely cause minor irritation.

The trial includes procedures like nerve blocks and bladder instillations. These are usually safe, but some people might feel temporary discomfort.

Since this study is in a late stage, earlier research has shown good safety for the treatments involved. Joining a trial like this means the treatments have met safety standards so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the multimodal care bundle for chronic pelvic pain because it offers a comprehensive approach that goes beyond typical treatments. Standard treatments often focus on one aspect of the condition, like medication for pain or physical therapy. However, this bundle combines several treatments, including pelvic floor physical therapy, behavioral health support, and medications targeting various symptoms like pain, urinary issues, and microbiome health. It also includes innovative procedures such as bladder instillations and nerve blocks. This holistic method aims to address multiple facets of chronic pelvic pain simultaneously, potentially leading to more effective and faster relief for patients.

What evidence suggests that this trial's treatments could be effective for chronic bladder pain?

This trial will compare a multimodal care bundle with usual care for managing chronic bladder pain. Research has shown that combining different treatments, like those in the multimodal care bundle, can effectively manage chronic bladder pain. This approach includes medications such as amitriptyline and gabapentin, which reduce pain by calming overactive nerves. It also involves physical therapy and mental health support to address both the body and mind's role in pain. Studies have found that using these treatments together improves symptoms more than using them alone. The treatment plan also targets urinary symptoms with medications for an overactive bladder and includes bladder instillations, which are bladder washes with medicine to directly relieve pain. Early results suggest that combining these treatments leads to better pain management for patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Jocelyn J Fitzgerald, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05658874

A Multidisciplinary, Multimodal Bundled Care Approach to ... The goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary ...

2. withpower.com withpower.com/trial/phase-3-cystitis-11-2022-47e37

Multimodal Bundled Care for Chronic Pelvic Pain The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain. The main questions the investigators ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05658874/a-multidisciplinary-multimodal-bundled-care-approach-to-chronic-pelvic-pain

A Multidisciplinary, Multimodal Bundled Care Approach to ... The goal of this clinical trial is to compare two different treatment patterns in patients with chronic bladder pain.

4. clinicaltrial.be clinicaltrial.be/en/details/178259?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

A Multidisciplinary, Multimodal Bundled Care Approach to... The goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05658874?tab=history&a=2

Record History | ver. 2: 2024-02-03 | NCT05658874 An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...