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

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ClinicalTrials.gov Identifier: NCT03468530
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

Brief 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

Condition or disease Intervention/treatment
Interstitial Cystitis Procedure: Transurethral ablation

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients
Actual Study Start Date : August 1, 2012
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Transurethral ablation
    transurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia


Primary Outcome Measures :
  1. change in recurrence-free survival time after ablation treatment [ Time Frame: Every three months for one year ]

Secondary Outcome Measures :
  1. changes in mean number of daytime frequency episodes [ Time Frame: Every three months for one year ]
  2. changes in mean number of nocturia episodes [ Time Frame: Every three months for one year ]
  3. changes in mean number of urgency episodes [ Time Frame: Every three months for one year ]
  4. Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) [ Time Frame: Every three months for one year ]
  5. Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score [ Time Frame: every 3months for one year ]
  6. Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) [ Time Frame: Every three months for one year ]
  7. Change score of Brief Pain Inventory-short form (BPI-sf) [ Time Frame: Every three months for one year ]
  8. Occurrence of adverse event [ Time Frame: Every three months for one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
tertiary hospital
Criteria

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.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468530


Contacts
Contact: Kwang Jin Ko, Ph.D. truelight8217@gmail.com

Locations
Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, MD, PhD    82-2-3410-3554    ksleedr@skku.edu   
Principal Investigator: Kyu-Sung Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: KYU-SUNG LEE, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03468530     History of Changes
Other Study ID Numbers: 2017-08-005
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases