Recruiting

Observational Study

Sponsor:

Philadelphia Urosurgical Associates

Code:

NCT02868775

Conditions

Cystitis, Interstitial

Painful Bladder Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

cystoscopy, bladder hydrodistention and bladder biopsy

Study Details

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 ID

NCT02868775

Start date

Sep, 2016

Status verified date

Jan, 2017

Completion date

Oct, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Interstitial cystitis/bladder pain syndrome

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

Interventions

cystoscopy, bladder hydrodistention and bladder biopsy

Primary outcome measure

  • Toll-like Receptor 4 protein analysis [ Time Frame: 1 year ]
  • Toll-like Receptor 4 mRNA expression in bladder biopsy [ Time Frame: 1 year ]
  • Toll-like Receptor 4 distribution and localization evaluation [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kristene Whitmore, MD

2158638100bladder1@aol.com

Nima M Shah, MD

2158638100nima.shah@drexelmed.edu

Locations

Hahnemann Urogynecology

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Nima M Shah, MD

215-863-8100nima.shah@drexelmed.edu

More Information

Sponsor

Philadelphia Urosurgical Associates

Last update posted

Jan 6, 2017

Last verified

Jan, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Philadelphia Urosurgical Associates on 2017-01-06.