Interstitial CystitisNCT02150811
Observational Study of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome
An observational study of Interstitial Cystitis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Interstitial Cystitis
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2016to 31 Jan 2017
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary care clinic
Who may be able to join
- must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
- PUF score ≥ 13
- cystoscopic record within 2 years
- Hunner ulcer lesion in cystoscopic finding
Who cannot join
- Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
- 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
Show all 14Show fewer
- Tuberculosis in urinary system
- 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
1 site in 1 country.
About this study
Official title: Longitudinal Change of Distribution Pattern of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome
The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome
Read the detailed description
This is observational, 12 months study
- Conditions
- Interstitial Cystitis
- 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of distribution pattern of Hunner's ulcer
Measured: 1 month, 6month, 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study start2 Jun 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Year
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, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150811
- Sponsor's protocol ID
- 20131119
- Status last verified
- Jul 2019
- First submitted
- 28 May 2014
- 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
- Longitudinal Change of Distribution Pattern of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT02150811
- Acronym / sponsor ID
- 20131119
- Conditions
- Interstitial Cystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 30 May 2014 (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 observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome
Detailed description
This is observational, 12 months study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hunner's ulcer | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic
Key inclusion criteria (6 listed)
- must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
- PUF score ≥ 13
- cystoscopic record within 2 years
Key exclusion criteria (14 listed)
- Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
- 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
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
Change of distribution pattern of Hunner's ulcer
Time frame: 1 month, 6month, 12month
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, Professor principal investigator
Asan Medical Center
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 Interstitial Cystitis, run by Asan Medical Center at 1 site 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 6 inclusion and 14 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 1 site 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?
Change of distribution pattern of Hunner's ulcer (time frame: 1 month, 6month, 12month). 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.