A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

NCT05658874 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: STUDY21060060
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Levator Spasm; Bladder Pain Syndrome; Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• --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 Outcomes (1)

• Healthcare Encounters Motivated on Pain

  Baseline to 12-month

Study Arms (2)

Multimodal care bundle

EXPERIMENTAL

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; Procedure: Operative Cystoscopy; Behavioral: Behavioral health consultation/therapy; Other: Pelvic floor physical therapy; Drug: Bladder Instillation; Drug: Vaginal estrogen; Drug: Methenamine; Drug: Amitriptyline/Gabapentin

Usual care

ACTIVE COMPARATOR

IC/PBS treatments as directed by Urogynecology specialist

Other: Usual Urogynecologic care

Interventions

Pelvic floor physical therapy OTHER

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

Multimodal care bundle

Usual Urogynecologic care OTHER

Usual care from practicing academic Urogynecologist

Usual care

Bladder Instillation DRUG

Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin

Multimodal care bundle

Vaginal estrogen DRUG

Topical vaginal estradiol application

Multimodal care bundle

Methenamine DRUG

UTI prevention/bladder therapeutic

Multimodal care bundle

Amitriptyline/Gabapentin DRUG

Part of multimodal pain therapy

Multimodal care bundle

Multimodal Bundle Drugs DRUG

multimodal pain therapy

Also known as: Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)

Multimodal care bundle

Operative Cystoscopy PROCEDURE

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

Multimodal care bundle

Behavioral health consultation/therapy BEHAVIORAL

Patient to see behavioral health/psychiatric care

Multimodal care bundle

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jocelyn Fitzgerald: lead

Study Sites (1)

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Therapeutics; Administration, Intravesical; Methenamine; Amitriptyline; Gabapentin

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Polyamines; Amines; Organic Chemicals; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This study was extremely challenging to recruit for because the majority of participants screened positive for symptoms of endometriosis; so we were unable to reach the recruitment numbers required to power our primary outcome.

Results Point of Contact

• Title: Jocelyn J. Fitzgerald
• Organization: University of Pittsburgh

fitzgeraldjj2@upmc.edu

412-641-7850

Study Officials

• Jocelyn J Fitzgerald, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single center, randomized pre-post intervention/prospective cohort study of usual Urogynecology care vs. multimodal, multidisciplinary care bundle (MMCB).

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 21, 2022
• Study Start: December 6, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: April 1, 2026
• Results First Posted: April 1, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)