A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

February 3, 2024 updated by: Jocelyn Fitzgerald
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

The goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary chronic pelvic pain clinic compared to "usual care" in an Urogynecology clinic.

Primary Aim:

To compare pre and post intervention self-evaluation of pain and function scores in women with chronic pain syndromes with a primary finding of urinary/bladder pain symptoms with or without levator spasm who undergo multi-disciplinary, bundled care compared with usual care in a Urogynecology clinic setting.

Secondary Aims:

a) To identify and phenotype "non-responders" to a bundled approach to Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain (IC/PBS/CPP).

Hypothesis: We hypothesize that a bundled, multidisciplinary care approach will significantly improve patient scores on validated outcomes questionnaires compared to usual care.

Methods:

All treatment plans, medications, and procedures recommended for patients involved in this study are within the current standards of care for IC/PBS/CPP, regardless of treatment arm and are known to be safe interventions.

Study Design: Single center, randomized pre-post intervention/prospective cohort study32 of usual FPMRS care vs. multimodal, multidisciplinary care bundle (MMCB).

Setting: Patients will be recruited from an outpatient Urogynecology clinic. They will subsequently be randomized to a Multidisciplinary chronic pelvic pain clinic at an alternate site vs. continuing usual outpatient care in Urogynecology as above.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • Inclusion Criteria:
  • Female patient 18 years of age or older
  • diagnosis of Interstitial Cystitis/Painful Bladder Syndrome, scoring 6 points or higher on O'Leary Sant Questionnaire
  • Exclusion Criteria:

Active pelvic or bladder infection within past 2 weeks

  • contraindications to medications or intervention therapeutics
  • inability to speak or read English
  • pelvic floor interventional procedure including bladder instillations 4 weeks prior to study recruitment
  • meets criteria for diagnostic laparoscopy
  • internal referral (to reduce severity bias)

Note: patients are not excluded for currently taking any medication on the treatment list.

Patients can be treated for UTI during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal care bundle

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)
Drug: Multimodal Bundle Drugs
multimodal pain therapy
Other Names:
  • Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)
Procedure: Operative Cystoscopy
Evaluate bladder and treat Hunner lesions with kenalog or fulguration as appropriate
Behavioral: Behavioral health consultation/therapy
Patient to see behavioral health/psychiatric care
Other: Pelvic floor physical therapy
Patient to have evaluation and treatment by a trained pelvic floor physical therapist
Drug: Bladder Instillation
Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin
Drug: Vaginal estrogen
Topical vaginal estradiol application
Drug: Methenamine
UTI prevention/bladder therapeutic
Drug: Amitriptyline/Gabapentin
Part of multimodal pain therapy
Active Comparator: Usual care
IC/PBS treatments as directed by Urogynecology specialist
Other: Usual Urogynecologic care
Usual care from practicing academic Urogynecologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
--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
Time Frame: 12 weeks
Validated Questionnaire for evaluating Interstitial Cystitis. Scale range ICSI 0-20, ICPI 0-16, total 0-36. Higher score=worse pain. Improvement of 1-2 point is consider clinically significant.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare encounters
Time Frame: 1 year
Number of encounters with the UPMC healthcare system
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jocelyn Fitzgerald

Investigators

  • Principal Investigator: Jocelyn J Fitzgerald, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY21060060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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