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| Name | Class |
|---|---|
| Drexel University College of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interstitial cystitis/bladder pain syndrome | These are the patients that will be evaluated in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cystoscopy, bladder hydrodistention and bladder biopsy | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Patients must be a candidate for cystoscopy, hydrodistention and bladder biopsy.
Participant must have subjective complaints of
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:
Exclusion Criteria:
To participate in the study subjects must not meet any of the following criteria:
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Female patients diagnosed with IC/BPS with a minimum O'Leary-Sant score of 8 on the ICSI, as well as 8 on the ICPI who are undergoing cystoscopy, hydrodistention and bladder biopsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristene Whitmore, MD | Contact | 2158638100 | bladder1@aol.com | |
| Nima M Shah, MD | Contact | 2158638100 | nima.shah@drexelmed.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hahnemann Urogynecology | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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Bladder biopsies
| 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 |
| 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 |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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