An observational study in Cystitis, Interstitial and Painful Bladder Syndrome, sponsored by Philadelphia Urosurgical Associates. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-01-06.
Sponsored by Philadelphia Urosurgical Associates · Observational
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.
227 studies on the registry are indexed under Cystitis, Interstitial; 32 are open to participants now.
This study's planned enrollment of 60 is below the median of 91 across 60 observational studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Philadelphia Urosurgical Associates is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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.
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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:
These are the patients that will be evaluated in this study.
Procedure: cystoscopy, bladder hydrodistention and bladder biopsy
Toll-like Receptor 4 protein analysis
Determine Toll-like Receptor 4 protein expression with western blot
Time frame: 1 year
Toll-like Receptor 4 mRNA expression in bladder biopsy
Determine Toll-like Receptor 4 mRNA expression with quantitative polymerase chain reaction
Time frame: 1 year
Toll-like Receptor 4 distribution and localization evaluation
Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry
Time frame: 1 year
Bladder symptom evaluation
Utilize O'Leary Sant Interstitial Cystitis Symptom and Problem Indices to evaluate subjective bladder symptom changes
Time frame: 28 days
Vaginal symptoms evaluation
Utilize pelvic floor impact questionnaire-7 to evaluate vaginal and pelvic symptoms
Time frame: 28 days
Female sexual function
Use female sexual function index questionnaire to evaluate female sexual function
Time frame: 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
Time frame: 28 days
Patient satisfaction
Use Global response assessment questionnaire
Time frame: 28 days
Bladder symptom evaluation
Utilize questionnaire: pelvic floor impact questionnaire-7
Time frame: 28 days
Plan to share: No
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This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Philadelphia Urosurgical Associates