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

NCT02868775 | Unknown

• 1 other identifier: TLR4001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Toll-like Receptor 4 protein analysis

  Determine Toll-like Receptor 4 protein expression with western blot

  1 year

• Toll-like Receptor 4 mRNA expression in bladder biopsy

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

  1 year

• Toll-like Receptor 4 distribution and localization evaluation

  Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry

  1 year

Secondary Outcomes (6)

• Bladder symptom evaluation

  28 days

• Vaginal symptoms evaluation

  28 days

• Female sexual function

  28 days

• Interstitial cystitis Flares

  28 days

• Patient satisfaction

  28 days

Study Arms (1)

Interstitial cystitis/bladder pain syndrome

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

Procedure: cystoscopy, bladder hydrodistention and bladder biopsy

Interventions

cystoscopy, bladder hydrodistention and bladder biopsy PROCEDURE

Interstitial cystitis/bladder pain syndrome

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients must be a candidate for cystoscopy, hydrodistention and bladder biopsy.
• Participant must have subjective complaints of
• urinary urgency, relieved with voiding, OR
• urinary frequency; ≥ 8 voids per day, OR
• pelvic pain, pressure, or discomfort
• \. 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.
• \. Age of subjects: Age of subjects will range from 18 to 90 years.
• \. 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.
• Participant must give written informed consent to participate in the study
• Participant must be able to make decisions for herself
• Participant must not have had a UTI within 7 days prior to start of the study
• Female participants who are with a positive pregnancy test

You may not qualify if:

• To participate in the study subjects must not meet any of the following criteria:
• Participant is currently pregnant or breastfeeding
• Participant has a positive urinary pregnancy test at the time of screening
• Participant is currently or has been on antibiotic therapy with the last 7 days prior to the start of the study
• Participant is currently in another trial
• Participant has an active S3 nerve stimulator implanted or has PTNS
• Participant has had intravesical botulinum toxin injection in 6 months prior to starting the study
• Participant has grade III or IV pelvic organ prolapse
• Participant has history of bladder cancer
• 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
• Participant has urinary frequency of less than 8 times/day
• Participant has bladder or lower ureteral calculi
• Participant has active genital herpes
• Participant has urethral diverticulum
• Participant has chemical cystitis

Sponsors & Collaborators

• Philadelphia Urosurgical Associates: lead
• Drexel University College of Medicine: collaborator

Study Sites (1)

Hahnemann Urogynecology

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bladder biopsies

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Kristene Whitmore, MD

CONTACT

2158638100; bladder1@aol.com

Nima M Shah, MD

CONTACT

2158638100; nima.shah@drexelmed.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head of Female Pelvic Medicine and Reconstructive Surgery

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 16, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)