A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

NCT ID: NCT05658874

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-10-31

Brief Summary

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.

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.

Conditions

Interstitial Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Multimodal Bundle Drugs

Intervention Type: DRUG

multimodal pain therapy

Operative Cystoscopy

Intervention Type: PROCEDURE

Evaluate bladder and treat Hunner lesions with kenalog or fulguration as appropriate

Behavioral health consultation/therapy

Intervention Type: BEHAVIORAL

Patient to see behavioral health/psychiatric care

Pelvic floor physical therapy

Intervention Type: OTHER

Patient to have evaluation and treatment by a trained pelvic floor physical therapist

Bladder Instillation

Intervention Type: DRUG

Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin

Vaginal estrogen

Intervention Type: DRUG

Topical vaginal estradiol application

Methenamine

Intervention Type: DRUG

UTI prevention/bladder therapeutic

Amitriptyline/Gabapentin

Intervention Type: DRUG

Part of multimodal pain therapy

Usual care

IC/PBS treatments as directed by Urogynecology specialist

Group Type: ACTIVE_COMPARATOR

Usual Urogynecologic care

Intervention Type: OTHER

Usual care from practicing academic Urogynecologist

Interventions

Multimodal Bundle Drugs

multimodal pain therapy

Intervention Type: DRUG

Operative Cystoscopy

Evaluate bladder and treat Hunner lesions with kenalog or fulguration as appropriate

Intervention Type: PROCEDURE

Behavioral health consultation/therapy

Patient to see behavioral health/psychiatric care

Intervention Type: BEHAVIORAL

Pelvic floor physical therapy

Patient to have evaluation and treatment by a trained pelvic floor physical therapist

Intervention Type: OTHER

Usual Urogynecologic care

Usual care from practicing academic Urogynecologist

Intervention Type: OTHER

Bladder Instillation

Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin

Intervention Type: DRUG

Vaginal estrogen

Topical vaginal estradiol application

Intervention Type: DRUG

Methenamine

UTI prevention/bladder therapeutic

Intervention Type: DRUG

Amitriptyline/Gabapentin

Part of multimodal pain therapy

Intervention Type: DRUG

Other Intervention Names

Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jocelyn Fitzgerald

OTHER

Sponsor Role: lead

Responsible Party

Jocelyn Fitzgerald

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jocelyn J Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY21060060

Identifier Type: -

Identifier Source: org_study_id