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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000026714 |
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Date of registration:
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27/03/2017 |
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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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RCT study of bladder instillation therapy in patients with refractory interstitial cystitis.
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Scientific title:
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RCT study of bladder instillation therapy in patients with refractory interstitial cystitis. - RCT study of bladder instillation therapy for refractory interstitial cystitis. |
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Date of first enrolment:
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2016/02/26 |
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Target sample size:
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20 |
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Recruitment status: |
Pending |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024393 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase II,III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Akira Nomiya |
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Address:
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1, Kanda-Izumicho, Chiyoda, Tokyo, 101-8643
Japan |
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Telephone:
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03-3862-9111 |
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Email:
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anomiya-jua@umin.ac.jp |
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Affiliation:
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Mitsui Memorial Hospital Department of Urology |
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Name:
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Akira Nomiya |
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Address:
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1, Kanda-Izumicho, Chiyoda, Tokyo, 101-8643
Japan |
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Telephone:
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03-3862-9111 |
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Email:
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anomiya-jua@umin.ac.jp |
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Affiliation:
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Mitsui Memorial Hospital Department of Urology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients who cannot fulfill the above inclusion criteria. 2. Patients with gross hematuria. 3. Patients with lidocaine allergy. 4. Patients who are regarded not suitable for this study.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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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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Treated with vesical instillation with heparin and alkalized lidocaine. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.
Treated with vesical instillation with heparin alone. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.
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Primary Outcome(s)
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Global response assessment at 3rd month of maintenance therapeutic phase.
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Secondary Outcome(s)
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1. daily urinary frequency, nocturnal urinary frequency, average voided volume per urination. 2. Maximum urine flow rate, average urine flow rate, residual urine volume. 3. O'Leary & Sant's symptom score, problem score, visual analogue scale for pain, overactive bladder symptom score, international prostate symptom score 4. adverse event at 6,12 the weeks after enrollment and 3rd,6th ,9th months at maintenance therapy.
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Source(s) of Monetary Support
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Mitsui Memorial Hospital
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Ethics review
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Status: YES
Approval date:
Contact:
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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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