Status:
TERMINATED
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.
Lead Sponsor:
Asan Medical Center
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
20+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01813565
Start Date
March 20 2013
End Date
December 1 2016
Last Update
July 5 2019
Active Locations (1)
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1
Asan medical center
Seoul, South Korea