Have you or your loved ones been diagnosed with interstitial cystitis?

You may be eligible to participate in a interstitial cystitis clinical trial.

Have you or your loved ones been diagnosed with interstitial cystitis? You may be eligible to participate in a interstitial cystitis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Interstitial Cystitis Clinical Trial in Philadelphia PA

NCT02868775 | Observational

Have you or your loved ones been diagnosed with interstitial cystitis?

You may be eligible to participate in a interstitial cystitis clinical trial.

Have you or your loved ones been diagnosed with interstitial cystitis? You may be eligible to participate in a interstitial cystitis clinical trial.

Recruiting

Female

18 - 90

Years old

This study is looking to recruit 60 Participants

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.

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Details for the 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 Title

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

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Toll-like Receptor 4 distribution and localization evaluation

Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry

1 year

Primary

Toll-like Receptor 4 mRNA expression in bladder biopsy

Determine Toll-like Receptor 4 mRNA expression with quantitative polymerase chain reaction

1 year

Primary

Toll-like Receptor 4 protein analysis

Determine Toll-like Receptor 4 protein expression with western blot

1 year

Secondary

Bladder symptom evaluation

Utilize questionnaire: pelvic floor impact questionnaire-7

28 days

Secondary

Patient satisfaction

Use Global response assessment questionnaire

28 days

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

Secondary

Female sexual function

Use female sexual function index questionnaire to evaluate female sexual function

28 days

Secondary

Bladder symptom evaluation

Utilize O'Leary Sant Interstitial Cystitis Symptom and Problem Indices to evaluate subjective bladder symptom changes

28 days

Secondary

Vaginal symptoms evaluation

Utilize pelvic floor impact questionnaire-7 to evaluate vaginal and pelvic symptoms

28 days

Study 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