Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients

October 30, 2023 updated by: KYU-SUNG LEE, Samsung Medical Center
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center, Sungkyunkwan University School of Medicine
        • Contact:
        • Principal Investigator:
          • Kyu-Sung Lee, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

tertiary hospital

Description

Inclusion Criteria:

  1. Male and female aged 18 yrs or greater
  2. Patients diagnosed with BPS(Bladder Pain Syndrome)
  3. Symptom persisted more than 6 months
  4. Pain VAS ≥4
  5. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) scores 12 or greater with pain and nocturia domain scores > 2.
  6. Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) >13
  7. No history of cystoscopy within 2yrs.

Exclusion Criteria:

  1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to BPS
  2. Child-bearing potential, pregnant or nursing women.
  3. Mean voided volume lesser than 40ml or over than 400ml.
  4. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
  5. Urinary tract infection during run-in periods.
  6. Genitourinary tuberculosis or bladder,urethral and prostate cancer
  7. Recurrent urinary tract infection
  8. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
  9. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in recurrence-free survival time after ablation treatment
Time Frame: Every three months for one year
Every three months for one year

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in mean number of daytime frequency episodes
Time Frame: Every three months for one year
Every three months for one year
changes in mean number of nocturia episodes
Time Frame: Every three months for one year
Every three months for one year
changes in mean number of urgency episodes
Time Frame: Every three months for one year
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
Every three months for one year
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
Time Frame: every 3months for one year
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
Every three months for one year
Change score of Brief Pain Inventory-short form (BPI-sf)
Time Frame: Every three months for one year
Every three months for one year
Occurrence of adverse event
Time Frame: Every three months for one year
Every three months for one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

March 11, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-08-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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