Trial record 16 of 46 for:    Open Studies | "Cystitis"

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. (see Contacts and Locations)
Verified May 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: May 28, 2014
Last verified: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 28, 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
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 01, 2014