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.
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Interstitial Cystitis |
Intervention | Drug: Hyaluronic acid/chondroitin sulfate |
Phase | N/A |
Sponsor | Asan Medical Center |
Responsible Party | Asan Medical Center |
ClinicalTrials.gov Identifier | NCT01813565 |
First Received | March 11, 2013 |
Last Updated | January 8, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | March 11, 2013 |
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Last Updated Date | January 8, 2014 |
Start Date | March 2013 |
Estimated Primary Completion Date | February 2015 |
Current Primary Outcome Measures | Change of pain scores on the Visual Analogue Scale [Time Frame: 1month, 3month, 6month] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
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. |
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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. |
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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Interstitial Cystitis |
Intervention | Drug: Hyaluronic acid/chondroitin sulfate Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder Other Names: Ialuril |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 32 |
Estimated Completion Date | February 2015 |
Estimated Primary Completion Date | March 2013 |
Eligibility Criteria | Inclusion Criteria: 1. must have experienced bladder pain, urinary urgency and urinary frequency, for at least 6 months prior to entry into the study 2. Pain VAS ≥4 3. O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem ≥ 12( and pain ≥2, and nocturia ≥ 2) 4. PUF score ≥ 13 5. cystoscopic record within 2 years 6. Hunner ulcer lesion in cystoscopic finding Exclusion Criteria: 1. 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 2. Patients who are pregnancy or, childbearing age without no contraception 3. Patients with voided volume <40 or, > 400ml 4. Patients with microscopic hematuria, (≥1+ in dipstick), If not excluded that no evidence of neoplastic tumor examination 5. Patients with urine culture showing evidence of urinary tract infection 1month prior to the study 6. Accompanied medical problem below - Tuberculosis in urinary system - Bladder cancer, urethral cancer, prostate cancer - Recurrent cystitis - anatomical disorder 7. Patients had prior surgery (eq, bladder augmentation, cystectomy 8. Patients with neurologic disorder 9. Patients with indwelling catheter or intermittent self-catheterization 10. Patients with psychologic problem |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Myung-Soo Choo, professor 82-2-3010-3735 mschoo@amc.seoul.kr |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01813565 |
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Other Study ID Numbers | 20130135 |
Has Data Monitoring Committee | Yes |
Information Provided By | Asan Medical Center |
Study Sponsor | Asan Medical Center |
Collaborators | Not Provided |
Investigators | Principal Investigator: Myung -Soo Choo, profesor Asan Medical Center |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Asan medical center | Seoul, Korea, Republic of Contact: Myung-Soo Choo, professor | 82-2-3010-3735 | mschoo@amc.seoul.krPrincipal Investigator: Myung-Soo Choo Recruiting |
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