Interstitial CystitisNCT01985880
The Efficacy of Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome
An observational study of Interstitial Cystitis, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy of biomarker in patient 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
- Interstitial Cystitis
- How many people
- 67 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 19 Nov 2013to 12 May 2016
- How long will I take part?
- 6 Months
- 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: patients >20 years old with interstitial cystitis control
Who may be able to join
- 1) must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study 2) Pain VAS ≥4 3) O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2) 4) PUF score ≥ 13 5) cystoscopic record within 2 years
Who cannot join
- Patients who are pregnancy or, childbearing age without no contraception
- Patients with voided volume <40 or, > 400ml
- Patients with microscopic hematuria, (≥1+ in dipstick), 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
Show all 13Show fewer
- Bladder cancer, urethral cancer, prostate cancer
- Recurrent cystitis
- anatomical disorder
- Patients had prior surgery (eq, bladder augmentation, cystectomy
- Patients with neurologic disorder
- Patients with indwelling catheter or intermittent self-catheterization
- Patients with psychologic 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: Experimental Study of Biomarker in Patient With Interstitial Cystitis/Painful Bladder
The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial cystitis/painful bladder syndrome
Read the detailed description
This is a observational study
- Conditions
- Interstitial Cystitis
- Keywords
- Biomarkers
- 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 |
|---|---|---|
| Hunner's ulcer interstitial cystitis | Hunner's ulcer interstitial cystitis | |
| non-ulcer interstitial cystitis | non-ulcer interstitial cystitis | |
| Control | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups
To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups
Measured: 1month
Secondary outcomes (2)
To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group
To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group
Measured: 1 month
TO compare of change of scores of questionnaires such as O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF), Visual Analogue Scale (Pain) between Hunner's ulcer group and non-ulcer group
TO compare of change of scores of questionnaires such as O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF), Visual Analogue Scale (Pain) between Hunner's ulcer group and non-ulcer group
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study start19 Nov 2013
- Primary completion12 May 2016
- Study completion12 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 6 Months
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, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985880
- Sponsor's protocol ID
- 2013-0616
- Status last verified
- Jul 2019
- First submitted
- 10 Nov 2013
- 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
- Experimental Study of Biomarker in Patient With Interstitial Cystitis/Painful Bladder
- ClinicalTrials.gov ID
- NCT01985880
- Acronym / sponsor ID
- 2013-0616
- Conditions
- Interstitial Cystitis
- Keywords
- Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 19 Nov 2013 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 15 Nov 2013 (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.
The purpose of this study is to evaluate efficacy of biomarker in patient with interstitial cystitis/painful bladder syndrome
Detailed description
This is a observational study
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hunner's ulcer interstitial cystitis | – | –Hunner's ulcer interstitial cystitis |
| non-ulcer interstitial cystitis | – | –non-ulcer interstitial cystitis |
| Control | – | –Control |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients >20 years old with interstitial cystitis control
Key inclusion criteria (1 listed)
- 1) must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study 2) Pain VAS ≥4 3) O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2) 4) PUF score ≥ 13 5) cystoscopic record within 2 years
Key exclusion criteria (13 listed)
- Patients who are pregnancy or, childbearing age without no contraception
- Patients with voided volume <40 or, > 400ml
- Patients with microscopic hematuria, (≥1+ in dipstick), 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
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
To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups
Time frame: 1month
To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups
2 secondary outcomes
To compare of changes voiding parameters after bladder biopsy between Hunner' ulcer group and non-ulcer group
Time frame: 1 month
TO compare of change of scores of questionnaires such as O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q), Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF), Visual Analogue Scale (Pain) between Hunner's ulcer group and non-ulcer group
Time frame: 1month
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, M.D. 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 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 1 inclusion and 13 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?
To compare of expression of the biomarker such as APF, HB-EGF, MCP-1 among the Hunner's ulcer interstitial cystitis and non-ulcer interstitial cystitis and control groups (time frame: 1month). 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.