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

NCT02868775 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2017-01-06

No results posted yet for this study

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

PROCEDURE

cystoscopy, bladder hydrodistention and bladder biopsy

Sponsors & Collaborators

  • Drexel University College of Medicine

    collaborator OTHER

  • Philadelphia Urosurgical Associates

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-06-30
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02868775 on ClinicalTrials.gov