Interstitial CystitisPhase 3NCT05658874
A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
A Phase 3 study testing Multimodal Bundle Drugs, Operative Cystoscopy and Behavioral health consultation/therapy in people with Interstitial Cystitis and Levator Spasm, run by Jocelyn Fitzgerald at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Interstitial Cystitis, Levator Spasm, Bladder Pain Syndrome
- What is being tested?
- Multimodal Bundle Drugs, Operative Cystoscopy and Behavioral health consultation/therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
Objectives:
The goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary chronic pelvic pain clinic compared to "usual care" in an Urogynecology clinic.
Primary Aim:
To compare pre and post intervention self-evaluation of pain and function scores in women with chronic pain syndromes with a primary finding of urinary/bladder pain symptoms with or without levator spasm who undergo multi-disciplinary, bundled care compared with usual care in a Urogynecology clinic setting.
Secondary Aims:
- To identify and phenotype "non-responders" to a bundled approach to Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain (IC/PBS/CPP).
Hypothesis: We hypothesize that a bundled, multidisciplinary care approach will significantly improve patient scores on validated outcomes questionnaires compared to usual care.
Methods:
All treatment plans, medications, and procedures recommended for patients involved in this study are within the current standards of care for IC/PBS/CPP, regardless of treatment arm and are known to be safe interventions.
Study Design: Single center, randomized pre-post intervention/prospective cohort study32 of usual FPMRS care vs. multimodal, multidisciplinary care bundle (MMCB).
Setting: Patients will be recruited from an outpatient Urogynecology clinic. They will subsequently be randomized to a Multidisciplinary chronic pelvic pain clinic at an alternate site vs. continuing usual outpatient care in Urogynecology as above.
- Conditions
- Interstitial Cystitis, Levator Spasm, Bladder Pain Syndrome
- Being tested
- Multimodal Bundle Drugs, Operative Cystoscopy, Behavioral health consultation/therapy, Pelvic floor physical therapy, Usual Urogynecologic care
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Bundle DrugsDrug
Also called Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)
multimodal pain therapy
Operative CystoscopyProcedure or surgery
Evaluate bladder and treat Hunner lesions with kenalog or fulguration as appropriate
Behavioral health consultation/therapyBehavioural
Patient to see behavioral health/psychiatric care
Pelvic floor physical therapyOther
Patient to have evaluation and treatment by a trained pelvic floor physical therapist
Usual Urogynecologic careOther
Usual care from practicing academic Urogynecologist
Bladder InstillationDrug
Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin
Vaginal estrogenDrug
Topical vaginal estradiol application
MethenamineDrug
UTI prevention/bladder therapeutic
Amitriptyline/GabapentinDrug
Part of multimodal pain therapy
| Study group | Role | What they receive |
|---|---|---|
| Multimodal care bundle | Experimental | Components of multimodal care bundle
1. MD Evaluation
2. On site pelvic floor physical therapy
3. Behavioral health consult with appropriate psychiatric referrals/treatments
4. Central sensitization/neurogenic pain:
Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid)
5. Urinary symptoms IC/PBS:
Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron)
6. Microbiome: Methenamine
7. Vaginal estrogen
At least once within 12 weeks of initial visit:
8. Operative cystoscopy
9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin)
10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc) Receives: Drug: Multimodal Bundle Drugs; Procedure: Operative Cystoscopy; Behavioral: Behavioral health consultation/therapy; Other: Pelvic floor physical therapy; Drug: Bladder Instillation; Drug: Vaginal estrogen; Drug: Methenamine; Drug: Amitriptyline/Gabapentin |
| Usual care | Active comparator | IC/PBS treatments as directed by Urogynecology specialist Receives: Other: Usual Urogynecologic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
--O'Leary Sant Questionnaire (OLS), Comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), Change at 12 Weeks From Baseline
This survey assesses IC/BPS symptoms and a change in > or equal to 4 points is considered clinically significant. A higher score change indicates less pain and urinary symptoms. The minimum possible score is 0. The maximum possible score is 37.
Measured: Baseline, 12 weeks
Secondary outcomes (1)
Healthcare Encounters Motivated on Pain
Number of encounters with the UPMC healthcare system that include emergency room visits, provider calls, provider visits, procedures, and other treatments based on documentation within their medical record.
Measured: Baseline to 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start6 Dec 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2025
Why it stopped: unable to reach the recruitment numbers required to power our primary outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, randomized pre-post intervention/prospective cohort study of usual Urogynecology care vs. multimodal, multidisciplinary care bundle (MMCB).
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jocelyn Fitzgerald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jocelyn Fitzgerald, University of Pittsburgh
- Investigators
- Jocelyn J Fitzgerald, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658874
- Sponsor's protocol ID
- STUDY21060060
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2022
- Last updated
- 1 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05658874
- Acronym / sponsor ID
- STUDY21060060
- Conditions
- Interstitial Cystitis, Levator Spasm, Bladder Pain Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to reach the recruitment numbers required to power our primary outcome
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jocelyn FitzgeraldUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Posted 1 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
The goals of this research program are to evaluate the patient-reported outcomes of a multimodal care bundle for patients presenting to a multidisciplinary chronic pelvic pain clinic compared to "usual care" in an Urogynecology clinic.
Primary Aim:
To compare pre and post intervention self-evaluation of pain and function scores in women with chronic pain syndromes with a primary finding of urinary/bladder pain symptoms with or without levator spasm who undergo multi-disciplinary, bundled care compared with usual care in a Urogynecology clinic setting.
Secondary Aims:
- To identify and phenotype "non-responders" to a bundled approach to Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain (IC/PBS/CPP).
Hypothesis: We hypothesize that a bundled, multidisciplinary care approach will significantly improve patient scores on validated outcomes questionnaires compared to usual care.
Methods:
All treatment plans, medications, and procedures recommended for patients involved in this study are within the current standards of care for IC/PBS/CPP, regardless of treatment arm and are known to be safe interventions.
Study Design: Single center, randomized pre-post intervention/prospective cohort study32 of usual FPMRS care vs. multimodal, multidisciplinary care bundle (MMCB).
Setting: Patients will be recruited from an outpatient Urogynecology clinic. They will subsequently be randomized to a Multidisciplinary chronic pelvic pain clinic at an alternate site vs. continuing usual outpatient care in Urogynecology as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, randomized pre-post intervention/prospective cohort study of usual Urogynecology care vs. multimodal, multidisciplinary care bundle (MMCB).
| Arm | Type | Receives |
|---|---|---|
| Multimodal care bundle | Experimental | Drug: Multimodal Bundle Drugs, Procedure: Operative Cystoscopy, Behavioral: Behavioral health consultation/therapy, Other: Pelvic floor physical therapy, Drug: Bladder Instillation, Drug: Vaginal estrogen, Drug: Methenamine, Drug: Amitriptyline/GabapentinComponents of multimodal care bundle 1. MD Evaluation 2. On site pelvic floor physical therapy 3. Behavioral health consult with appropriate psychiatric referrals/treatments 4. Central sensitization/neurogenic pain: Amitriptyline 10-50mg Or Gabapentin (doses range from 100mg po tid to 600mg po tid) 5. Urinary symptoms IC/PBS: Spasm: Overactive bladder medication chosen based on patient characteristics/insurance, dose may be increased as tolerated (Oxybutynin/Trospium/Detrol vs. Mirabegron) 6. Microbiome: Methenamine 7. Vaginal estrogen At least once within 12 weeks of initial visit: 8. Operative cystoscopy 9. Bladder instillations x 6 weeks (lidocaine, heparin, sodium bicarb, Kenalog, gentamicin) 10. Pudendal/Levator and/or Obturator internus nerve block (120mg Kenalog and 0.25% Marcaine, total 23cc) |
| Usual care | Active comparator | Other: Usual Urogynecologic careIC/PBS treatments as directed by Urogynecology specialist |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Bundle DrugsAlso: Overactive Bladder Medication( Trospium/Oxybutynin/Detrol vs. Mirabegron)multimodal pain therapy | Drug | Multimodal care bundle |
| Operative CystoscopyEvaluate bladder and treat Hunner lesions with kenalog or fulguration as appropriate | Procedure or surgery | Multimodal care bundle |
| Behavioral health consultation/therapyPatient to see behavioral health/psychiatric care | Behavioural | Multimodal care bundle |
| Pelvic floor physical therapyPatient to have evaluation and treatment by a trained pelvic floor physical therapist | Other | Multimodal care bundle |
| Usual Urogynecologic careUsual care from practicing academic Urogynecologist | Other | Usual care |
| Bladder InstillationIntravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin | Drug | Multimodal care bundle |
| Vaginal estrogenTopical vaginal estradiol application | Drug | Multimodal care bundle |
| MethenamineUTI prevention/bladder therapeutic | Drug | Multimodal care bundle |
| Amitriptyline/GabapentinPart of multimodal pain therapy | Drug | Multimodal care bundle |
Primary outcome
--O'Leary Sant Questionnaire (OLS), Comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), Change at 12 Weeks From Baseline
Time frame: Baseline, 12 weeks
This survey assesses IC/BPS symptoms and a change in > or equal to 4 points is considered clinically significant. A higher score change indicates less pain and urinary symptoms. The minimum possible score is 0. The maximum possible score is 37.
1 secondary outcome
Healthcare Encounters Motivated on Pain
Time frame: Baseline to 12-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
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Investigation of PEMF Therapy for Female Patients With IC/BPS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn J Fitzgerald, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multimodal Bundle Drugs, Operative Cystoscopy and Behavioral health consultation/therapy in people with Interstitial Cystitis and Levator Spasm, run by Jocelyn Fitzgerald at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
--O'Leary Sant Questionnaire (OLS), Comprised of Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), Change at 12 Weeks From Baseline (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.