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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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ClinicalTrials.gov Identifier: NCT01813565
Recruitment Status : Recruiting
First Posted : March 19, 2013
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Drug: Hyaluronic acid/chondroitin sulfate Not Applicable

Detailed Description:
This is a randomized, parallel, 6 month period study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : March 2013
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Additional instillation of hyaluronic acid/chondroitin sulfate
Transurethral resection of bladder ulcer + instillation of hyaluronic acid/chondroitin sulfate
Drug: Hyaluronic acid/chondroitin sulfate
Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder
Other Name: Ialuril

Active Comparator: Transurethral resection of bladder ulcer
Transurethral resection of bladder ulcer
Drug: Hyaluronic acid/chondroitin sulfate
Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder
Other Name: Ialuril




Primary Outcome Measures :
  1. Change of pain scores on the Visual Analogue Scale [ Time Frame: 1month, 3month, 6month ]

Secondary Outcome Measures :
  1. Duration of symptom improvement [ Time Frame: 1month, 3month, 6month ]
  2. Changes of frequency and urgency on voiding diary [ Time Frame: 1month, 3month, 6month ]
  3. Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) [ Time Frame: 1month, 6month ]
  4. Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score [ Time Frame: 6month ]
  5. Occurrence of adverse event [ Time Frame: 6month ]
  6. Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) [ Time Frame: 1month, 6month ]
  7. Change score of EQ-5D Health Questionnaire [ Time Frame: 1month, 6month ]
  8. Change score of Brief Pain Inventory-short form (BPI-sf) [ Time Frame: 1month, 6month ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813565


Contacts
Contact: Myung-Soo Choo, professor 82-2-3010-3735 mschoo@amc.seoul.kr

Locations
Korea, Republic of
Asan medical center Recruiting
Seoul, Korea, Republic of
Contact: Myung-Soo Choo, professor    82-2-3010-3735    mschoo@amc.seoul.kr   
Principal Investigator: Myung-Soo Choo         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Myung -Soo Choo, profesor Asan Medical Center

Responsible Party: Myung-Soo Choo, Profesor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01813565     History of Changes
Other Study ID Numbers: 20130135
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents