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unable to reach the recruitment numbers required to power our primary outcome
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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.
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:
a) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal care bundle | Experimental | Components of multimodal care bundle
|
|
| Usual care | Active Comparator | IC/PBS treatments as directed by Urogynecology specialist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Bundle Drugs | Drug | multimodal pain therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| --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. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12-month |
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Active pelvic or bladder infection within past 2 weeks
Note: patients are not excluded for currently taking any medication on the treatment list.
Patients can be treated for UTI during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Jocelyn J Fitzgerald, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
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Chronic Pelvic Pain Study, UPMC Magee's Women's Hospital, Recruited from 12/6/2022 to 9/25/2024
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| ID | Title | Description |
|---|---|---|
| FG000 | Multimodal Care Bundle | Components of multimodal care bundle
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2024 |
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Single center, randomized pre-post intervention/prospective cohort study of usual Urogynecology care vs. multimodal, multidisciplinary care bundle (MMCB).
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| Operative Cystoscopy | Procedure | Evaluate bladder and treat Hunner lesions with kenalog or fulguration as appropriate |
|
| Behavioral health consultation/therapy | Behavioral | Patient to see behavioral health/psychiatric care |
|
| Pelvic floor physical therapy | Other | Patient to have evaluation and treatment by a trained pelvic floor physical therapist |
|
| Usual Urogynecologic care | Other | Usual care from practicing academic Urogynecologist |
|
| Bladder Instillation | Drug | Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin |
|
| Vaginal estrogen | Drug | Topical vaginal estradiol application |
|
| Methenamine | Drug | UTI prevention/bladder therapeutic |
|
| Amitriptyline/Gabapentin | Drug | Part of multimodal pain therapy |
|
| FG001 | Usual Care | IC/PBS treatments as directed by Urogynecology specialist |
| Baseline Visit and Survey Completion |
|
| 6-week visit and Survey Completion |
|
| 12-week visit and Survey Completion |
|
| 6-month visit and Survey Completion |
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| 1-year visit and Survey Completion |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multimodal Care Bundle | Components of multimodal care bundle
|
| BG001 | Usual Care | IC/PBS treatments as directed by Urogynecology specialist |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Count of Participants | Participants |
| ||||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||||
| Menopausal Status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | --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. | Posted | Mean | Standard Deviation | O' Leary Sant Score | Baseline, 12 weeks |
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| |||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | Encounters | Baseline to 12-month |
|
|
Entire study period; 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multimodal Care Bundle | Components of multimodal care bundle
| 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | Usual Care | IC/PBS treatments as directed by Urogynecology specialist | 0 | 10 | 0 | 10 | 0 | 10 |
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This study was extremely challenging to recruit for because the majority of participants screened positive for symptoms of endometriosis; so we were unable to reach the recruitment numbers required to power our primary outcome.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jocelyn J. Fitzgerald | University of Pittsburgh | 412-641-7850 | fitzgeraldjj2@upmc.edu |
| Mar 11, 2026 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000283 | Administration, Intravesical |
| D008709 | Methenamine |
| D000639 | Amitriptyline |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000287 | Administration, Topical |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Ages 43-55 years |
|
| Ages 56-68 years |
|
| Ages 69+ years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Healthy weight: BMI 18.5-24.9 |
|
| Overweight: BMI 25-29.9 |
|
| Obese: BMI >30 |
|
| Former Smoker |
|
| Never Smoked |
|
| Postmenopausal, no HRT |
|
| Postmenopausal, HRT |
|
| Uncertain |
|
| Counts |
|---|
| Participants |
|
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