Chronic Interstitial CystitisNCT02331472
The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome (Pilot Study)
An observational study of Chronic Interstitial Cystitis, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
This study is to evaluate the efficacy of urine biomarker in patients with interstitial cystitis/painful bladder syndrome Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Interstitial Cystitis
- How many people
- 80 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 3 Feb 2015to 14 Jan 2016
- How long will I take part?
- 1 Month
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Interstitial cystitis
Who may be able to join
- must have experienced bladder pain, urinary urgency and frequency for at least 6 months prior to entry into the study
- Pain VAS >4
- PUF score >13
- ICQ score >12
- 4) cystoscopic record within 2years
Who cannot join
- Patients who are pregnancy or, childbearing age without no contraception
- Patient with microscopic hematuria, if not excluded that no evidence of neoplastic tumor examination
- patients with urine culture showing evidence of urinary tract infection 1month prior to the study
- Accompanied medical problem below
- Tuberculosis in urinary system
- Bladder cancer, urethral cancer, Prostate cancer
Show all 12Show fewer
- Recurrent cystitis
- Anatomical disorder
- Patients had prior surgery (bladder augmentation, cystectomy)
- Patients with neurologic disorder
- Patients with indwelling catheter or intermittent self-catheterization
- Patients with psychological problem
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center
Seoul, 138-222
Asan medical center Institutional review board
Seoul, 138-736
About this study
Official title: The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome
This study is to evaluate the efficacy of urine biomarker in patients with interstitial cystitis/painful bladder syndrome
- Conditions
- Chronic Interstitial Cystitis
- Keywords
- interstitial cystitis, biomarker
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Interstitial cystitis | Patients who have been diagnosed with interstitial cystitis/bladder pain syndrome. The group includes both patients with or without Hunner lesion on cystoscopy | |
| Control | Adult participants without history of interstitial cystitis/bladder pain syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups
Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups
Measured: 1day
Secondary outcomes (2)
Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups
Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups
Measured: 1day
Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale
Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study start3 Feb 2015
- Primary completion14 Jan 2016
- Study completion14 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-Soo Choo, Asan Medical Center
- Investigators
- Myung-Soo Choo, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331472
- Sponsor's protocol ID
- 2014-1220
- Status last verified
- Jul 2019
- First submitted
- 1 Jan 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome
- ClinicalTrials.gov ID
- NCT02331472
- Acronym / sponsor ID
- 2014-1220
- Conditions
- Chronic Interstitial Cystitis
- Keywords
- interstitial cystitis, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 3 Feb 2015 (actual)
- Primary completion
- 14 Jan 2016 (actual)
- Study completion
- 14 Jan 2016 (actual)
- First posted
- 6 Jan 2015 (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 study is to evaluate the efficacy of urine biomarker in patients with interstitial cystitis/painful bladder syndrome
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interstitial cystitis | – | –Patients who have been diagnosed with interstitial cystitis/bladder pain syndrome. The group includes both patients with or without Hunner lesion on cystoscopy |
| Control | – | –Adult participants without history of interstitial cystitis/bladder pain syndrome |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Interstitial cystitis
Key inclusion criteria (5 listed)
- must have experienced bladder pain, urinary urgency and frequency for at least 6 months prior to entry into the study
- Pain VAS >4
- PUF score >13
- ICQ score >12
- 4) cystoscopic record within 2years
Key exclusion criteria (12 listed)
- Patients who are pregnancy or, childbearing age without no contraception
- Patient with microscopic hematuria, if not excluded that no evidence of neoplastic tumor examination
- patients with urine culture showing evidence of urinary tract infection 1month prior to the study
- Accompanied medical problem below
- Patients had prior surgery (bladder augmentation, cystectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups
Time frame: 1day
Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups
2 secondary outcomes
Difference of RNA expression of the urine biomarker between Hunner ulcer interstitial cystitis and non-ulcer interstitial cystitis groups
Time frame: 1day
Difference of RNA expression of the urine biomarker in interstitial cystitis according to pain score on the visual analogue scale
Time frame: 1day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Myung-Soo Choo, MD, PhD principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Interstitial Cystitis, run by Asan Medical Center at 2 sites in South Korea.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of RNA expression of the urine biomarker between the interstitial cystitis and control groups (time frame: 1day). 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 5 Jul 2019.