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

• Conditions: Painful Bladder Syndrome; Cystitis, Interstitial
• Interventions: Procedure: cystoscopy, bladder hydrodistention and bladder biopsy

• Registration Number: NCT02868775
• Lead Sponsor: Philadelphia Urosurgical Associates

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-16
• Study Start: 2016-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-06
• Primary Completion: 2017-06
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

3. 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.

4. Age of subjects: Age of subjects will range from 18 to 90 years.

5. 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.

6. Other inclusion criteria:

7. Participant must give written informed consent to participate in the study

8. Participant must be able to make decisions for herself

9. Participant must not have had a UTI within 7 days prior to start of the study

10. 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Toll-like Receptor 4 protein analysis	1 year	Determine Toll-like Receptor 4 protein expression with western blot
Toll-like Receptor 4 mRNA expression in bladder biopsy	1 year	Determine Toll-like Receptor 4 mRNA expression with quantitative polymerase chain reaction
Toll-like Receptor 4 distribution and localization evaluation	1 year	Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry

Secondary Outcome Measures

Name	Time	Method
Bladder symptom evaluation	28 days	Utilize questionnaire: pelvic floor impact questionnaire-7
Vaginal symptoms evaluation	28 days	Utilize pelvic floor impact questionnaire-7 to evaluate vaginal and pelvic symptoms
Female sexual function	28 days	Use female sexual function index questionnaire to evaluate female sexual function
Interstitial cystitis Flares	28 days	Patients will record bladder pain scores and changes in urinary urgency with the bladder diary to evaluate flares following cystoscopy, hydrodistention
Patient satisfaction	28 days	Use Global response assessment questionnaire

Trial Locations

Locations (1)

Hahnemann Urogynecology; 🇺🇸 Philadelphia, Pennsylvania, United States