Clinical trial NCT02868775: A Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome
Official title: A Pilot Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystitis, Interstitial
Painful Bladder Syndrome
Lead sponsor: Philadelphia Urosurgical Associates
Sponsor class: OTHER
Collaborators: name: Drexel University College of Medicine
First posted: 2016-08-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Toll-like Receptor 4 protein analysis
timeFrame: 1 year
measure: Toll-like Receptor 4 mRNA expression in bladder biopsy
timeFrame: 1 year
measure: Toll-like Receptor 4 distribution and localization evaluation
timeFrame: 1 year
Secondary outcomes:
measure: Bladder symptom evaluation
timeFrame: 28 days
measure: Vaginal symptoms evaluation
timeFrame: 28 days
measure: Female sexual function
timeFrame: 28 days
measure: Interstitial cystitis Flares
timeFrame: 28 days
measure: Patient satisfaction
timeFrame: 28 days
measure: Bladder symptom evaluation
timeFrame: 28 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann Urogynecology
state: Pennsylvania
Study officials:
References: