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

NCT ID: NCT02868775

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-10-31

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.

Conditions

Cystitis, Interstitial; Painful Bladder Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Interstitial cystitis/bladder pain syndrome

These are the patients that will be evaluated in this study.

cystoscopy, bladder hydrodistention and bladder biopsy

Intervention Type: PROCEDURE

Interventions

cystoscopy, bladder hydrodistention and bladder biopsy

Intervention Type: PROCEDURE

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Drexel University College of Medicine

OTHER

Sponsor Role: collaborator

Philadelphia Urosurgical Associates

OTHER

Sponsor Role: lead

Responsible Party

Kristene Whitmore

Division Head of Female Pelvic Medicine and Reconstructive Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hahnemann Urogynecology

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristene Whitmore, MD

Role: CONTACT

bladder1@aol.com

2158638100

Nima M Shah, MD

Role: CONTACT

nima.shah@drexelmed.edu

2158638100

Facility Contacts

Nima M Shah, MD

Role: primary

nima.shah@drexelmed.edu

215-863-8100

Other Identifiers

TLR4001

Identifier Type: -

Identifier Source: org_study_id