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Recruiting
NCT05658874
A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
Conditions: Interstitial Cystitis
Sex: Female
Ages: 18 Years – 99 Years
Phase: PHASE3
Enrollment: 80
Sponsor: Jocelyn Fitzgerald
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Female patient 18 years of age or olderdiagnosis of Interstitial Cystitis/Painful Bladder Syndrome, scoring 6 points or higher on O'Leary Sant QuestionnaireExclusion Criteria:Active pelvic or bladder infection within past 2 weekscontraindications to medications or intervention therapeuticsinability to speak or read Englishpelvic floor interventional procedure including bladder instillations 4 weeks prior to study recruitmentmeets criteria for diagnostic laparoscopyinternal 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.
Source: ClinicalTrials.gov (NCT05658874). StuddyBuddy aggregates publicly available trial information.