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

NCT03468530 | Completed

• 1 other identifier: 2017-08-005
• Study Type: observational
• Target: 442
• Locations: 1 country
• Sites: 1

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

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• change in recurrence-free survival time after ablation treatment

  Every three months for one year

Secondary Outcomes (8)

• changes in mean number of daytime frequency episodes

  Every three months for one year

• changes in mean number of nocturia episodes

  Every three months for one year

• changes in mean number of urgency episodes

  Every three months for one year

• Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)

  Every three months for one year

• Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score

  every 3months for one year

Interventions

Transurethral ablation PROCEDURE

transurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

tertiary hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: March 16, 2018
• Study Start: August 1, 2012
• Primary Completion: December 31, 2013
• Study Completion: July 18, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)