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

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03468530
• Other study ID #: 2017-08-005
• Status: Recruiting
• Start date: August 1, 2012
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Samsung Medical Center
• Contact: Kwang Jin Ko, Ph.D.
• Email: truelight8217[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.-

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in recurrence-free survival time after ablation treatment		Every three months for one year
Secondary	changes in mean number of daytime frequency episodes		Every three months for one year
Secondary	changes in mean number of nocturia episodes		Every three months for one year
Secondary	changes in mean number of urgency episodes		Every three months for one year
Secondary	Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)		Every three months for one year
Secondary	Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score		every 3months for one year
Secondary	Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)		Every three months for one year
Secondary	Change score of Brief Pain Inventory-short form (BPI-sf)		Every three months for one year
Secondary	Occurrence of adverse event		Every three months for one year