Endoscopic treatment for Hunner lesions in bladder pain syndrome patients

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

This study is testing if a special procedure to treat Hunner lesions can help people with bladder pain syndrome feel better and improve their quality of life over time.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT03468530 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of transurethral ablation of Hunner lesions in patients diagnosed with interstitial cystitis/bladder pain syndrome (IC/BPS). It aims to assess the long-term outcomes and characteristics of Hunner lesions following the procedure. Patients will be monitored for symptom relief and overall quality of life improvements over time. The study includes a range of assessments to ensure comprehensive data collection on patient responses.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of bladder pain syndrome and persistent symptoms for more than six months.

Not a fit: Patients with a history of certain surgical interventions or those with specific urinary tract conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain and improve the quality of life for patients suffering from bladder pain syndrome.

How similar studies have performed: While there is limited data on this specific approach, similar interventions for bladder pain syndrome have shown promise in improving patient outcomes.

Eligibility 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.-

Where this trial is running

Seoul

• Samsung Medical Center, Sungkyunkwan University School of Medicine — Seoul, Korea, Republic of (RECRUITING)

Study contacts

• Study coordinator: Kwang Jin Ko, Ph.D.

Conditions: Interstitial Cystitis