A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jocelyn Fitzgerald
• Treatments: Amitriptyline; Estrogens; Gabapentin; Methenamine; Methenamine hippurate; Methenamine mandelate; Mirabegron; Oxybutynin

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.