A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

Phase 3TerminatedNCT05658874

Jocelyn Fitzgerald26 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

Interventions

Multimodal Bundle DrugsDRUG

multimodal pain therapy

Operative CystoscopyPROCEDURE

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

Behavioral health consultation/therapyBEHAVIORAL

Patient to see behavioral health/psychiatric care

Pelvic floor physical therapyOTHER

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

Usual Urogynecologic careOTHER

Usual care from practicing academic Urogynecologist

Bladder InstillationDRUG

Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin

Vaginal estrogenDRUG

Topical vaginal estradiol application

MethenamineDRUG

UTI prevention/bladder therapeutic

Amitriptyline/GabapentinDRUG

Part of multimodal pain therapy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

* 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.

Outcomes

Primary Outcomes

--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.

Time frame: Baseline, 12 weeks

Secondary Outcomes

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.

Time frame: Baseline to 12-month