ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 141 for:    Cystitis, Interstitial

Observational Study of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02150811
Recruitment Status : Recruiting
First Posted : May 30, 2014
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center

Brief Summary:
The purpose of this study is to observe change of distribution pattern of Hunner's ulcer in patient with interstitial cystitis/bladder pain syndrome

Condition or disease
Interstitial Cystitis

Detailed Description:
This is observational, 12 months study

Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Longitudinal Change of Distribution Pattern of Hunner's Ulcer in Patient With Interstitial Cystitis/Bladder Pain Syndrome
Study Start Date : March 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Hunner's ulcer



Primary Outcome Measures :
  1. Change of distribution pattern of Hunner's ulcer [ Time Frame: 1 month, 6month, 12month ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary care clinic
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): NCT02150811


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, 138-736
Contact: Myung-Soo Choo, professor    82-2-3010-3735    mschoo@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Myung-Soo Choo, Professor Asan Medical Center

Responsible Party: Myung-Soo Choo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02150811     History of Changes
Other Study ID Numbers: 20131119
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases