Status:
COMPLETED
Therapeutic Effects of Endoscopic Ablation of Hunner Lesions in Interstitial Cystitis/ Bladder Pain Syndrome Patients
Lead Sponsor:
Samsung Medical Center
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
18+ years
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.-
Key Trial Info
Start Date :
August 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 18 2025
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT03468530
Start Date
August 1 2012
End Date
July 18 2025
Last Update
July 22 2025
Active Locations (1)
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1
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea, 135-710