NCT05658874

A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Jocelyn Fitzgerald · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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
• Levator Spasm
• Bladder Pain Syndrome

Interventions

Type	Name	Description
DRUG	Multimodal Bundle Drugs	multimodal pain therapy
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
OTHER	Usual Urogynecologic care	Usual care from practicing academic Urogynecologist
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

Timeline

• Start date: 2022-12-06
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2022-12-21
• Last updated: 2026-04-01
• Results posted: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study