Therapeutic Effects of Endoscopic Ablation of Hunner Lesi... | NCT03468530

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

NCT03468530

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jul 22, 2025Actual

Enrollment

442Actual

Phase

Not provided

Conditions

Interstitial Cystitis

Interventions

Transurethral ablation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2012Actual

Primary Completion Date

Dec 31, 2013Actual

Completion Date

Jul 18, 2025Actual

First Submitted Date

Dec 13, 2017

First Submission Date that Met QC Criteria

Mar 11, 2018

First Posted Date

Mar 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2025

Last Update Posted Date

Jul 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

442Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transurethral ablation	Procedure	transurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in recurrence-free survival time after ablation treatment		Every three months for one year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

tertiary hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center, Sungkyunkwan University School of Medicine		Seoul		135-710	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020728	Transurethral Resection of Prostate

Ancestor Terms

ID	Term
D011468	Prostatectomy
D013521	Urologic Surgical Procedures, Male
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided