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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2022 |
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Main ID: |
NCT03463499 |
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Date of registration:
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25/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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September 22, 2017 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03463499 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group 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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Key inclusion & exclusion criteria
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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
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 and Chondroitin Sulfate
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Primary Outcome(s)
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change in recurrence rate in Hyaluronic Acid and Chondroitin Sulfate instillation group after transurethral resection treatment
[Time Frame: Every 3 months for 2 years]
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Secondary Outcome(s)
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changes in mean number of urgency episodes
[Time Frame: Every 3 months for 2 years]
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Patient Global Assessment
[Time Frame: at the end of the treatment(2 years)]
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Change score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q)
[Time Frame: Every 3 months for 2 years]
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changes in mean number of nocturia episodes
[Time Frame: Every 3 months for 2 years]
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Occurrence of adverse event
[Time Frame: Every 3 months for 2 years]
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Change score of Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF)
[Time Frame: Every 3 months for 2 years]
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changes in mean number of daytime frequency episodes
[Time Frame: Every 3 months for 2 years]
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Score of Global Response Assessment (GRA)
[Time Frame: Every 3 months for 2 years]
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Secondary ID(s)
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2017-08-106
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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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