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 range

18 Years – 99 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Interstitial Cystitis trials