A Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome

Study Overview
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Brief Summary
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This is a prospective pilot study, with a recruitment goal of 60 patients. Patients who are female, above the age of 18, and with a diagnosis of IC/BPS based on clinical criteria and O'Leary Sant ICPI and ICSI scores undergoing cystoscopy, hydrodistention and bladder biopsy will be included. The bladder biopsies will be evaluated for TLR4 expression, and sent for histological assessment of mast cell count. Additionally, data will be collected at baseline, day of surgery, day 7, day 14 and day 28. Data will include validated questionnaires, lower urinary tract symptoms, and recorded pain medication use.

Official Title
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A Pilot Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome

Conditions
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Cystitis, Interstitial, Painful Bladder Syndrome

Intervention / Treatment
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* Procedure: cystoscopy, bladder hydrodistention and bladder biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be a candidate for cystoscopy, hydrodistention and bladder biopsy. Participant must have subjective complaints of urinary urgency, relieved with voiding, OR urinary frequency; ≥ 8 voids per day, OR pelvic pain, pressure, or discomfort 2. Gender of subjects: Subjects in this study will be female. Pregnant women and breastfeeding women will be excluded due to unknown risk of study medication on pregnancy and fetus or nursing infants. 3. Age of subjects: Age of subjects will range from 18 to 90 years. 4. Racial and ethnic origin: There are no enrollment restrictions based upon race or ethnic origin. The racial and ethnic distribution of subjects is entirely based on the population of patients at the study site. 5. Other inclusion criteria: Participant must give written informed consent to participate in the study Participant must be able to make decisions for herself Participant must not have had a UTI within 7 days prior to start of the study Female participants who are with a positive pregnancy test Exclusion Criteria: To participate in the study subjects must not meet any of the following criteria: Participant is currently pregnant or breastfeeding Participant has a positive urinary pregnancy test at the time of screening Participant is currently or has been on antibiotic therapy with the last 7 days prior to the start of the study Participant is currently in another trial Participant has an active S3 nerve stimulator implanted or has PTNS Participant has had intravesical botulinum toxin injection in 6 months prior to starting the study Participant has grade III or IV pelvic organ prolapse Participant has history of bladder cancer Participant has a neurological disease including, but not limited to, multiple sclerosis, Parkinson's disease, Alzheimer's disease, spinal cord injury, brain injury, stroke or dementia Participant has urinary frequency of less than 8 times/day Participant has bladder or lower ureteral calculi Participant has active genital herpes Participant has urethral diverticulum Participant has chemical cystitis Participant has radiation or tuberculosis cystitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interstitial cystitis/bladder pain syndrome<br>These are the patients that will be evaluated in this study. | Procedure: cystoscopy, bladder hydrodistention and bladder biopsy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toll-like Receptor 4 protein analysis | Determine Toll-like Receptor 4 protein expression with western blot | 1 year | 
| Toll-like Receptor 4 mRNA expression in bladder biopsy | Determine Toll-like Receptor 4 mRNA expression with quantitative polymerase chain reaction | 1 year | 
| Toll-like Receptor 4 distribution and localization evaluation | Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder symptom evaluation | Utilize O'Leary Sant Interstitial Cystitis Symptom and Problem Indices to evaluate subjective bladder symptom changes | 28 days | 
| Vaginal symptoms evaluation | Utilize pelvic floor impact questionnaire-7 to evaluate vaginal and pelvic symptoms | 28 days | 
| Female sexual function | Use female sexual function index questionnaire to evaluate female sexual function | 28 days | 
| Interstitial cystitis Flares | Patients will record bladder pain scores and changes in urinary urgency with the bladder diary to evaluate flares following cystoscopy, hydrodistention | 28 days | 
| Patient satisfaction | Use Global response assessment questionnaire | 28 days | 
| Bladder symptom evaluation | Utilize questionnaire: pelvic floor impact questionnaire-7 | 28 days |