Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01813565 |
Date of registration:
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11/03/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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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Scientific title:
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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. |
Date of first enrolment:
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March 20, 2013 |
Target sample size:
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15 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT01813565 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Myung -Soo Choo, profesor |
Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Drug: Hyaluronic acid/chondroitin sulfate
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Primary Outcome(s)
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Change of pain scores on the Visual Analogue Scale
[Time Frame: 1month, 3month, 6month]
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Secondary Outcome(s)
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Duration of symptom improvement
[Time Frame: 1month, 3month, 6month]
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Occurrence of adverse event
[Time Frame: 6month]
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Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
[Time Frame: 1month, 6month]
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Change score of Brief Pain Inventory-short form (BPI-sf)
[Time Frame: 1month, 6month]
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Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
[Time Frame: 1month, 6month]
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Change score of EQ-5D Health Questionnaire
[Time Frame: 1month, 6month]
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Changes of frequency and urgency on voiding diary
[Time Frame: 1month, 3month, 6month]
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Score of Global Response Assessment (GRA), Patient Global Assessment (PGA) score
[Time Frame: 6month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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