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

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ClinicalTrials.gov Identifier: NCT02868775
Recruitment Status : Unknown
Verified January 2017 by Kristene Whitmore, Philadelphia Urosurgical Associates.
Recruitment status was:  Recruiting
First Posted : August 16, 2016
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
Drexel University College of Medicine
Information provided by (Responsible Party):
Kristene Whitmore, 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.

Condition or disease Intervention/treatment
Cystitis, Interstitial Painful Bladder Syndrome Procedure: cystoscopy, bladder hydrodistention and bladder biopsy

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome
Study Start Date : September 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Toll-like Receptor 4 protein analysis [ Time Frame: 1 year ]
    Determine Toll-like Receptor 4 protein expression with western blot

  2. Toll-like Receptor 4 mRNA expression in bladder biopsy [ Time Frame: 1 year ]
    Determine Toll-like Receptor 4 mRNA expression with quantitative polymerase chain reaction

  3. Toll-like Receptor 4 distribution and localization evaluation [ Time Frame: 1 year ]
    Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry


Secondary Outcome Measures :
  1. Bladder symptom evaluation [ Time Frame: 28 days ]
    Utilize O'Leary Sant Interstitial Cystitis Symptom and Problem Indices to evaluate subjective bladder symptom changes

  2. Vaginal symptoms evaluation [ Time Frame: 28 days ]
    Utilize pelvic floor impact questionnaire-7 to evaluate vaginal and pelvic symptoms

  3. Female sexual function [ Time Frame: 28 days ]
    Use female sexual function index questionnaire to evaluate female sexual function

  4. Interstitial cystitis Flares [ Time Frame: 28 days ]
    Patients will record bladder pain scores and changes in urinary urgency with the bladder diary to evaluate flares following cystoscopy, hydrodistention

  5. Patient satisfaction [ Time Frame: 28 days ]
    Use Global response assessment questionnaire

  6. Bladder symptom evaluation [ Time Frame: 28 days ]
    Utilize questionnaire: pelvic floor impact questionnaire-7


Biospecimen Retention:   Samples With DNA
Bladder biopsies


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868775


Contacts
Contact: Kristene Whitmore, MD 2158638100 bladder1@aol.com
Contact: Nima M Shah, MD 2158638100 nima.shah@drexelmed.edu

Locations
United States, Pennsylvania
Hahnemann Urogynecology Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Nima M Shah, MD    215-863-8100    nima.shah@drexelmed.edu   
Sponsors and Collaborators
Philadelphia Urosurgical Associates
Drexel University College of Medicine

Responsible Party: Kristene Whitmore, Division Head of Female Pelvic Medicine and Reconstructive Surgery, Philadelphia Urosurgical Associates
ClinicalTrials.gov Identifier: NCT02868775     History of Changes
Other Study ID Numbers: TLR4001
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases