A Multidisciplinary, Multimodal Bundled Care Approach to 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 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: Terminated
• Conditions: Interstitial Cystitis; Bladder Pain Syndrome; Levator Spasm
• Intervention / Treatment: Drug: Multimodal Bundle Drugs; Procedure: Operative Cystoscopy; Behavioral: Behavioral health consultation/therapy; Other: Pelvic floor physical therapy; Drug: Bladder Instillation; Drug: Vaginal estrogen; Drug: Methenamine; Drug: Amitriptyline/Gabapentin; Other: Usual Urogynecologic 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal care bundle; Components of multimodal care bundle; MD Evaluation; On site pelvic floor physical therapy; Behavioral health consult with appropriate psychiatric referrals/treatments; Central sensitization/neurogenic pain:Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid); 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); Microbiome: Methenamine; Vaginal estrogenAt least once within 12 weeks of initial visit:; Operative cystoscopy; Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin); 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), Change at 12 Weeks From Baseline	This survey assesses IC/BPS symptoms and a change in > or equal to 4 points is considered clinically significant. A higher score change indicates less pain and urinary symptoms. The minimum possible score is 0. The maximum possible score is 37.	Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Encounters Motivated on Pain	Number of encounters with the UPMC healthcare system that include emergency room visits, provider calls, provider visits, procedures, and other treatments based on documentation within their medical record.	Baseline to 12-month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 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 (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial; Amino Acids, Peptides, and Proteins; Organic Chemicals; Drug Administration Routes; Drug Therapy; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Amines; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Adamantane; Bridged-Ring Compounds; Acids, Carbocyclic; Dibenzocycloheptenes; Benzocycloheptenes; Cyclohexanecarboxylic Acids; Polyamines; Administration, Topical; Gabapentin; Amitriptyline; Methenamine; Therapeutics; Administration, Intravesical
• 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
• product manufactured in and exported from the U.S.: No