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

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.

Study Overview

• Status: Unknown
• Conditions: Cystitis, Interstitial; Painful Bladder Syndrome
• Intervention / Treatment: Procedure: cystoscopy, bladder hydrodistention and bladder biopsy

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Hahnemann Urogynecology
      • Contact: Nima M Shah, MD; Phone Number: 215-863-8100; Email: nima.shah@drexelmed.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Patients must be a candidate for cystoscopy, hydrodistention and bladder biopsy.

2. Participant must have subjective complaints of

   1. urinary urgency, relieved with voiding, OR
   2. urinary frequency; ≥ 8 voids per day, OR
   3. 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:

1. Participant must give written informed consent to participate in the study
2. Participant must be able to make decisions for herself
3. Participant must not have had a UTI within 7 days prior to start of the study
4. 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:

1. Participant is currently pregnant or breastfeeding
2. Participant has a positive urinary pregnancy test at the time of screening
3. Participant is currently or has been on antibiotic therapy with the last 7 days prior to the start of the study
4. Participant is currently in another trial
5. Participant has an active S3 nerve stimulator implanted or has PTNS
6. Participant has had intravesical botulinum toxin injection in 6 months prior to starting the study
7. Participant has grade III or IV pelvic organ prolapse
8. Participant has history of bladder cancer
9. 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
10. Participant has urinary frequency of less than 8 times/day
11. Participant has bladder or lower ureteral calculi
12. Participant has active genital herpes
13. Participant has urethral diverticulum
14. Participant has chemical cystitis
15. Participant has radiation or tuberculosis cystitis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Interstitial cystitis/bladder pain syndrome; These are the patients that will be evaluated in this study.	Procedure: cystoscopy, bladder hydrodistention and bladder biopsy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Philadelphia Urosurgical Associates
• Collaborators: Drexel University College of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Estimate): January 6, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease; Syndrome; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: TLR4001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No