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

Recruiting

• Conditions: Interstitial Cystitis

• Registration Number: NCT03468530
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08-01
• Primary Completion: 2013-12-31
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2018-03-11
• Study First Posted: 2018-03-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Study Completion: 2040-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

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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.-

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in recurrence-free survival time after ablation treatment	Every three months for one year

Secondary Outcome Measures

Name	Time	Method
changes in mean number of daytime frequency episodes	Every three months for one year
Occurrence of adverse event	Every three months for one year
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score	every 3months for one year
changes in mean number of urgency episodes	Every three months for one year
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)	Every three months for one year
changes in mean number of nocturia episodes	Every three months for one year
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)	Every three months for one year
Change score of Brief Pain Inventory-short form (BPI-sf)	Every three months for one year

Trial Locations

Locations (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of