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Trial record 6 of 158 for:    interstitial cystitis

The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients

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ClinicalTrials.gov Identifier: NCT03463499
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

Brief Summary:
The efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate after transurethral resection of Hunner lesion in interstitial cystitis/bladder pain syndrome patients. To analyze the number and timing of recurrence based on a long-term follow-up.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Drug: Hyaluronic Acid and Chondroitin Sulfate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyaluronic Acid and Chondroitin Sulfate
Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.
Drug: Hyaluronic Acid and Chondroitin Sulfate
Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.




Primary Outcome Measures :
  1. change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment [ Time Frame: Every 3 months for 2 years ]

Secondary Outcome Measures :
  1. changes in mean number of daytime frequency episodes [ Time Frame: Every 3 months for 2 years ]
  2. changes in mean number of nocturia episodes [ Time Frame: Every 3 months for 2 years ]
  3. changes in mean number of urgency episodes [ Time Frame: Every 3 months for 2 years ]
  4. Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) [ Time Frame: Every 3 months for 2 years ]
  5. Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF) [ Time Frame: Every 3 months for 2 years ]
  6. Score of Global Response Assessment (GRA) [ Time Frame: Every 3 months for 2 years ]
  7. Patient Global Assessment [ Time Frame: at the end of the treatment(2 years) ]
  8. Occurrence of adverse event [ Time Frame: Every 3 months for 2 years ]


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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. Male and female aged 20 yrs or greater
  2. Patients diagnosed with Hunner lesion in IC(interstitial cystitis)/BPS(Bladder Pain Syndrome) and who is scheduled to undergo transurethral resection
  3. Symptom persisted more than 6 months
  4. Pain VAS ≥4

Exclusion Criteria:

  1. History of augmentation cystoplasty or previous transurethral coagulation/resection due to IC/BPS
  2. Child-bearing potential, pregnant or nursing women.
  3. Hematuria exceeds 1+ in the urinary dipstick (dipstick) examination.
  4. Urinary tract infection during run-in periods.
  5. Genitourinary tuberculosis or bladder,urethral and prostate cancer
  6. Recurrent urinary tract infection
  7. History of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or Cesarean section,prostate operation or treatment etc within 6months.
  8. Neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
  9. Using a indwelling catheter or execution of intermittent self catheterization

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): NCT03463499


Contacts
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Contact: Sangok Park 82-2-6007-5419 missusu@naver.com

Locations
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Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, MD, PhD    82-2-3410-3554    ksleedr@skku.edu   
Principal Investigator: Kyu-Sung Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: KYU-SUNG LEE, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03463499     History of Changes
Other Study ID Numbers: 2017-08-106
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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