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

Painful Bladder Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02868775
• Other study ID #: TLR4001
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: January 4, 2017
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: January 2017
• Source: Philadelphia Urosurgical Associates
• Contact: Kristene Whitmore, MD
• Phone: 2158638100
• Email: bladder1[@]aol.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Painful Bladder Syndrome
• Syndrome

Intervention

Procedure:
• cystoscopy, bladder hydrodistention and bladder biopsy

Locations

Country	Name	City	State
United States	Hahnemann Urogynecology	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Philadelphia Urosurgical Associates	Drexel University College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toll-like Receptor 4 protein analysis	Determine Toll-like Receptor 4 protein expression with western blot	1 year	No
Primary	Toll-like Receptor 4 mRNA expression in bladder biopsy	Determine Toll-like Receptor 4 mRNA expression with quantitative polymerase chain reaction	1 year	No
Primary	Toll-like Receptor 4 distribution and localization evaluation	Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry	1 year	No
Secondary	Bladder symptom evaluation	Utilize O'Leary Sant Interstitial Cystitis Symptom and Problem Indices to evaluate subjective bladder symptom changes	28 days	No
Secondary	Vaginal symptoms evaluation	Utilize pelvic floor impact questionnaire-7 to evaluate vaginal and pelvic symptoms	28 days	No
Secondary	Female sexual function	Use female sexual function index questionnaire to evaluate female sexual function	28 days	No
Secondary	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	No
Secondary	Patient satisfaction	Use Global response assessment questionnaire	28 days	No
Secondary	Bladder symptom evaluation	Utilize questionnaire: pelvic floor impact questionnaire-7	28 days	No