Cystitis, InterstitialNCT02868775
A Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome
An observational study of Cystitis, Interstitial and Painful Bladder Syndrome, run by Philadelphia Urosurgical Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Cystitis, Interstitial, Painful Bladder Syndrome
- What is being tested?
- cystoscopy, bladder hydrodistention and bladder biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- 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.
Show all 13Show fewer
- 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:
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- Participant has radiation or tuberculosis cystitis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hahnemann Urogynecology
Philadelphia, Pennsylvania, 19107
Nima M Shah, MD, 215-863-8100, nima.shah@drexelmed.edu
About this study
Official title: A Pilot Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome
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
- Being tested
- cystoscopy, bladder hydrodistention and bladder biopsy
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystoscopy, bladder hydrodistention and bladder biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Interstitial cystitis/bladder pain syndrome | These are the patients that will be evaluated in this study. Receives: Procedure: cystoscopy, bladder hydrodistention and bladder biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toll-like Receptor 4 protein analysis
Determine Toll-like Receptor 4 protein expression with western blot
Measured: 1 year
Toll-like Receptor 4 mRNA expression in bladder biopsy
Determine Toll-like Receptor 4 mRNA expression with quantitative polymerase chain reaction
Measured: 1 year
Toll-like Receptor 4 distribution and localization evaluation
Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry
Measured: 1 year
Secondary outcomes (6)
Bladder symptom evaluation
Utilize O'Leary Sant Interstitial Cystitis Symptom and Problem Indices to evaluate subjective bladder symptom changes
Measured: 28 days
Vaginal symptoms evaluation
Utilize pelvic floor impact questionnaire-7 to evaluate vaginal and pelvic symptoms
Measured: 28 days
Female sexual function
Use female sexual function index questionnaire to evaluate female sexual function
Measured: 28 days
Interstitial cystitis Flares
Patients will record bladder pain scores and changes in urinary urgency with the bladder diary to evaluate flares following cystoscopy, hydrodistention
Measured: 28 days
Patient satisfaction
Use Global response assessment questionnaire
Measured: 28 days
Bladder symptom evaluation
Utilize questionnaire: pelvic floor impact questionnaire-7
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis, InterstitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philadelphia Urosurgical Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University College of Medicine
- Responsible party
- Principal investigator, Kristene Whitmore, Philadelphia Urosurgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868775
- Sponsor's protocol ID
- TLR4001
- Status last verified
- Jan 2017
- First submitted
- 9 Aug 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Role of Toll-like Receptor-4 Expression in Patients With Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT02868775
- Acronym / sponsor ID
- TLR4001
- Conditions
- Cystitis, Interstitial, Painful Bladder Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Philadelphia Urosurgical AssociatesUniversity, hospital or other
- Collaborators
- Drexel University College of Medicine
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interstitial cystitis/bladder pain syndrome | – | Procedure: cystoscopy, bladder hydrodistention and bladder biopsyThese are the patients that will be evaluated in this study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Patients must be a candidate for cystoscopy, hydrodistention and bladder biopsy.
- Participant must have subjective complaints of
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cystoscopy, bladder hydrodistention and bladder biopsy | Procedure or surgery | Interstitial cystitis/bladder pain syndrome |
Primary outcome
Toll-like Receptor 4 protein analysis
Time frame: 1 year
Determine Toll-like Receptor 4 protein expression with western blot
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
Toll-like Receptor 4 distribution and localization evaluation
Time frame: 1 year
Determine Toll-like Receptor 4 distribution and localization with immunohistochemistry
6 secondary outcomes
Bladder symptom evaluation
Time frame: 28 days
Vaginal symptoms evaluation
Time frame: 28 days
Female sexual function
Time frame: 28 days
Interstitial cystitis Flares
Time frame: 28 days
Patient satisfaction
Time frame: 28 days
Bladder symptom evaluation
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Cystitis, Interstitial
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystitis, Interstitial and Painful Bladder Syndrome, run by Philadelphia Urosurgical Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristene Whitmore, MD (2158638100, bladder1@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toll-like Receptor 4 protein analysis (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.