Trial record 17 of 35 for:    Open Studies | "Cystitis, Interstitial"

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.

This study is currently recruiting participants.
Verified January 2014 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01813565
First received: March 11, 2013
Last updated: January 8, 2014
Last verified: January 2014
  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.


Condition Intervention
Interstitial Cystitis
Drug: Hyaluronic acid/chondroitin sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Change of pain scores on the Visual Analogue Scale [ Time Frame: 1month, 3month, 6month ] [ Designated as safety issue: Yes ]

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 ]

Estimated Enrollment: 32
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

This is a randomized, parallel, 6 month period study.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Myung-Soo Choo, Profesor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01813565     History of Changes
Other Study ID Numbers: 20130135
Study First Received: March 11, 2013
Last Updated: January 8, 2014
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014