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.
ConditionInterstitial Cystitis
InterventionDrug: Hyaluronic acid/chondroitin sulfate
PhaseN/A
SponsorAsan Medical Center
Responsible PartyAsan Medical Center
ClinicalTrials.gov IdentifierNCT01813565
First ReceivedMarch 11, 2013
Last UpdatedJanuary 8, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateMarch 11, 2013
Last Updated DateJanuary 8, 2014
Start DateMarch 2013
Estimated Primary Completion DateFebruary 2015
Current Primary Outcome MeasuresChange of pain scores on the Visual Analogue Scale [Time Frame: 1month, 3month, 6month] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • Duration of symptom improvement [Time Frame: 1month, 3month, 6month] [Designated as safety issue: No]
  • Changes of frequency and urgency on voiding diary [Time Frame: 1month, 3month, 6month] [Designated as safety issue: No]
  • Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) [Time Frame: 1month, 6month] [Designated as safety issue: No]
  • Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score [Time Frame: 6month] [Designated as safety issue: No]
  • Occurrence of adverse event [Time Frame: 6month] [Designated as safety issue: Yes]
  • Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) [Time Frame: 1month, 6month] [Designated as safety issue: No]
  • Change score of EQ-5D Health Questionnaire [Time Frame: 1month, 6month] [Designated as safety issue: No]
  • Change score of Brief Pain Inventory-short form (BPI-sf) [Time Frame: 1month, 6month] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleThe 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 TitleThe 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 TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionInterstitial Cystitis
InterventionDrug: Hyaluronic acid/chondroitin sulfate
Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder
Other Names:
Ialuril
Study Arm (s)
  • Experimental: Additional instillation of hyaluronic acid/chondroitin sulfate
    Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate
  • Active Comparator: Transurethral resection of bladder ulcer
    Transurethral resection of bladder ulcer

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment32
Estimated Completion DateFebruary 2015
Estimated Primary Completion DateMarch 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
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsContact: Myung-Soo Choo, professor
82-2-3010-3735
mschoo@amc.seoul.kr
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01813565
Other Study ID Numbers20130135
Has Data Monitoring CommitteeYes
Information Provided ByAsan Medical Center
Study SponsorAsan Medical Center
CollaboratorsNot Provided
Investigators Principal Investigator: Myung -Soo Choo, profesor Asan Medical Center
Verification DateJanuary 2014

Locations[ + expand ][ + ]

Asan medical center
Seoul, Korea, Republic of
Contact: Myung-Soo Choo, professor | 82-2-3010-3735 | mschoo@amc.seoul.kr
Principal Investigator: Myung-Soo Choo
Recruiting