A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
TerminatedPhase 3NCT05658874
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
- Conditions
- Interstitial Cystitis
- Levator Spasm
- Bladder Pain Syndrome
- Interventions
- Drug: Multimodal Bundle Drugs
- Procedure: Operative Cystoscopy
- Behavioral: Behavioral health consultation/therapy
- Other: Pelvic floor physical therapy
- Other: Usual Urogynecologic care
- Drug: Bladder Instillation
- Drug: Vaginal estrogen
- Drug: Methenamine
- Drug: Amitriptyline/Gabapentin
- Sponsor
- Jocelyn Fitzgerald
- Organization
- University of Pittsburgh
- Start date
- 2022-12-06
- Primary completion
- 2024-12-30
- Sex
- Female
- Age range
- from 18 Years to 99 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
* 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05658874