The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.
Primary Purpose
Interstitial Cystitis
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hyaluronic acid/chondroitin sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis
Eligibility Criteria
Inclusion Criteria:
- must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
- Pain VAS ≥4
- O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
- PUF score ≥ 13
- cystoscopic record within 2 years
- Hunner ulcer lesion in cystoscopic finding
Exclusion Criteria:
- Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
- Patients who are pregnancy or, childbearing age without no contraception
- Patients with voided volume <40 or, > 400ml
- Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
- Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
Accompanied medical problem below
- Tuberculosis in urinary system
- Bladder cancer, urethral cancer, prostate cancer
- Recurrent cystitis
- anatomical disorder
- Patients had prior surgery (eq, bladder augmentation, cystectomy
- Patients with neurologic disorder
- Patients with indwelling catheter or intermittent self-catheterization
- Patients with psychologic problem
Sites / Locations
- Asan medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Additional instillation of hyaluronic acid/chondroitin sulfate
Transurethral resection of bladder ulcer
Arm Description
Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate
Transurethral resection of bladder ulcer
Outcomes
Primary Outcome Measures
Change of pain scores on the Visual Analogue Scale
Change of pain scores on the Visual Analogue Scale
Secondary Outcome Measures
Duration of symptom improvement
Duration of symptom improvement
Changes of frequency and urgency on voiding diary
Changes of frequency and urgency on voiding diary
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
Score of Global Response Assessment (GRA), Patient Global Assessment
Occurrence of adverse event
Occurrence of adverse event
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale
Change score of EQ-5D Health Questionnaire
Change score of EQ-5D Health Questionnaire
Change score of Brief Pain Inventory-short form (BPI-sf)
Change score of Brief Pain Inventory-short form (BPI-sf)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01813565
Brief Title
The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.
Official Title
The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
No benefit of intravesical instillation of Hyaluronic Acid/Chondroitin Sulfate
Study Start Date
March 20, 2013 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis.
Detailed Description
This is a randomized, parallel, 6 month period study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Additional instillation of hyaluronic acid/chondroitin sulfate
Arm Type
Experimental
Arm Description
Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate
Arm Title
Transurethral resection of bladder ulcer
Arm Type
Active Comparator
Arm Description
Transurethral resection of bladder ulcer
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid/chondroitin sulfate
Other Intervention Name(s)
Ialuril
Intervention Description
Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder
Primary Outcome Measure Information:
Title
Change of pain scores on the Visual Analogue Scale
Description
Change of pain scores on the Visual Analogue Scale
Time Frame
1month, 3month, 6month
Secondary Outcome Measure Information:
Title
Duration of symptom improvement
Description
Duration of symptom improvement
Time Frame
1month, 3month, 6month
Title
Changes of frequency and urgency on voiding diary
Description
Changes of frequency and urgency on voiding diary
Time Frame
1month, 3month, 6month
Title
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Description
Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
Time Frame
1month, 6month
Title
Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
Description
Score of Global Response Assessment (GRA), Patient Global Assessment
Time Frame
6month
Title
Occurrence of adverse event
Description
Occurrence of adverse event
Time Frame
6month
Title
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
Description
Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale
Time Frame
1month, 6month
Title
Change score of EQ-5D Health Questionnaire
Description
Change score of EQ-5D Health Questionnaire
Time Frame
1month, 6month
Title
Change score of Brief Pain Inventory-short form (BPI-sf)
Description
Change score of Brief Pain Inventory-short form (BPI-sf)
Time Frame
1month, 6month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study
Pain VAS ≥4
O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2)
PUF score ≥ 13
cystoscopic record within 2 years
Hunner ulcer lesion in cystoscopic finding
Exclusion Criteria:
Scheduled for or use of intravesical therapy (eg, bladder distention,transurethral resection of bladder ulcer, instillation) during or within 6months prior to the study and use of pentosan polysulfate sodium within 1 months prior to the study
Patients who are pregnancy or, childbearing age without no contraception
Patients with voided volume <40 or, > 400ml
Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination
Patients with urine culture showing evidence of urinary tract infection 1month prior to the study
Accompanied medical problem below
Tuberculosis in urinary system
Bladder cancer, urethral cancer, prostate cancer
Recurrent cystitis
anatomical disorder
Patients had prior surgery (eq, bladder augmentation, cystectomy
Patients with neurologic disorder
Patients with indwelling catheter or intermittent self-catheterization
Patients with psychologic problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung -Soo Choo, profesor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.
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