NCT02868775

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Philadelphia Urosurgical Associates · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cystitis, Interstitial
• Painful Bladder Syndrome

Interventions

Type	Name	Description
PROCEDURE	cystoscopy, bladder hydrodistention and bladder biopsy

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-06-01
• Completion: 2017-10-01
• First posted: 2016-08-16
• Last updated: 2017-01-06

Locations

1 site across 1 country: United States