Clinical trial NCT05658874: A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
Official title: A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Interstitial Cystitis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, randomized pre-post intervention/prospective cohort study of usual Urogynecology care vs. multimodal, multidisciplinary care bundle (MMCB).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: --O'Leary Sant Questionnaire (OLS), comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), at 12 weeks from baseline MCID: 4 points for ICSI Change in O'Leary Sant Questionnaire Scores >4 points
timeFrame: 12 weeks
Secondary outcomes:
measure: Healthcare encounters
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jocelyn J Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
References: