Interstitial CystitisNCT03468530
Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients
An observational study of Interstitial Cystitis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the characteristics of HLs based on a long-term follow-up Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Transurethral ablation
- Type of treatment
- Surgery or procedure
- How many people
- 442 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2012to 18 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary hospital
Who may be able to join
- Male and female aged 18 yrs or greater
- Patients diagnosed with BPS(Bladder Pain Syndrome)
- Symptom persisted more than 6 months
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores > 2.
- Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) >13
- No history of cystoscopy within 2yrs.
Who cannot join
- History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
- Child-bearing potential, pregnant or nursing women.
- Mean voided volume lesser than 40ml or over than 400ml.
- Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
- Urinary tract infection during run-in periods.
- Genitourinary tuberculosis or bladder,urethral and prostate cancer
Show all 9Show fewer
- Recurrent urinary tract infection
- History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
- Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the characteristics of HLs based on a long-term follow-up
- Conditions
- Interstitial Cystitis
- Being tested
- Transurethral ablation
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral ablationProcedure or surgery
transurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
change in recurrence-free survival time after ablation treatment
Measured: Every three months for one year
Secondary outcomes (8)
changes in mean number of daytime frequency episodes
Measured: Every three months for one year
changes in mean number of nocturia episodes
Measured: Every three months for one year
changes in mean number of urgency episodes
Measured: Every three months for one year
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Measured: Every three months for one year
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
Measured: every 3months for one year
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Measured: Every three months for one year
Change score of Brief Pain Inventory-short form (BPI-sf)
Measured: Every three months for one year
Occurrence of adverse event
Measured: Every three months for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Aug 2012
- Primary completion31 Dec 2013
- Study completion18 Jul 2025
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 Samsung 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
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468530
- Sponsor's protocol ID
- 2017-08-005
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2017
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients
- ClinicalTrials.gov ID
- NCT03468530
- Acronym / sponsor ID
- 2017-08-005
- Conditions
- Interstitial Cystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 16 Mar 2018 (actual)
- 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.
efficacy of endoscopic ablation of Hunner lesions in patients with IC/BPS and the characteristics of HLs based on a long-term follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary hospital
Key inclusion criteria (7 listed)
- Male and female aged 18 yrs or greater
- Patients diagnosed with BPS(Bladder Pain Syndrome)
- Symptom persisted more than 6 months
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores > 2.
Key exclusion criteria (9 listed)
- History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
- Child-bearing potential, pregnant or nursing women.
- Mean voided volume lesser than 40ml or over than 400ml.
- Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
- Urinary tract infection during run-in periods.
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 |
|---|---|---|
| Transurethral ablationtransurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia | Procedure or surgery | – |
Primary outcome
change in recurrence-free survival time after ablation treatment
Time frame: Every three months for one year
8 secondary outcomes
changes in mean number of daytime frequency episodes
Time frame: Every three months for one year
changes in mean number of nocturia episodes
Time frame: Every three months for one year
changes in mean number of urgency episodes
Time frame: Every three months for one year
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Time frame: Every three months for one year
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
Time frame: every 3months for one year
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Time frame: Every three months for one year
Change score of Brief Pain Inventory-short form (BPI-sf)
Time frame: Every three months for one year
Occurrence of adverse event
Time frame: Every three months for one year
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 22 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Samsung 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 7 inclusion and 9 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 22 Jul 2025. 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 in recurrence-free survival time after ablation treatment (time frame: Every three months for one year). 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 22 Jul 2025.