A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

Interstitial Cystitis Clinical Trial

Official title:

A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658874
• Other study ID #: STUDY21060060
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Judy Gruss, RN
• Phone: 4126415388
• Email: grussja[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Pelvic Pain

Intervention

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
• Usual Urogynecologic care
Usual care from practicing academic Urogynecologist

Drug:
• Bladder Instillation
Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin
• Vaginal estrogen
Topical vaginal estradiol application
• Methenamine
UTI prevention/bladder therapeutic
• Amitriptyline/Gabapentin
Part of multimodal pain therapy

Locations

Country	Name	City	State
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Jocelyn Fitzgerald

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	--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	Validated Questionnaire for evaluating Interstitial Cystitis. Scale range ICSI 0-20, ICPI 0-16, total 0-36. Higher score=worse pain. Improvement of 1-2 point is consider clinically significant.	12 weeks
Secondary	Healthcare encounters	Number of encounters with the UPMC healthcare system	1 year