TerminatedPhase 3

A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain

Stopped: unable to reach the recruitment numbers required to power our primary outcome

United States26 participantsStarted 2022-12-06

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

What they're measuring

--O'Leary Sant Questionnaire (OLS), Comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), Change at 12 Weeks From Baseline

Timeframe: Baseline, 12 weeks

Trial details

NCT IDNCT05658874

SponsorJocelyn Fitzgerald

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

Results submitted2026-01-05