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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16 December 2017 |
Main ID: |
NCT03076762 |
Date of registration:
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01/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Comparative Study Suburothelial and Trigonal Botulinum Toxin A Injection in Treatment of Interstitial Cystitis
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Scientific title:
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Comparative Study of the Efficacy and Safety Between Suburothelial and Trigonal Intravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Randomized, Clinical Trial |
Date of first enrolment:
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March 2015 |
Target sample size:
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60 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03076762 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Hann-Chorng HC Kuo, M.D. |
Address:
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Telephone:
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886-3-8561825 |
Email:
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hck@tzuchi.com.tw |
Affiliation:
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Name:
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Hann-Chorng Kuo, M.D. |
Address:
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Telephone:
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886-3-8561825 |
Email:
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hck@tzuchi.com.tw |
Affiliation:
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Name:
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Hann-Chorng HC Kuo, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Urology, Buddhist Tzu Chi General Hospital, Hualien |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients have been diagnosed as IC/BPS based on characteristic symptoms and
cystoscopic findings of glomerulations, petechia, or mucosal fissures after
hydrodistention
2. Patients have been treated with at least two types of treatment modalities including
non-steroid anti-inflammatory drugs, oral PPS, intravesical instillation of heparin,
hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms
remained unchanged or relapsed.
3. Patients who have bladder pain VAS of 3 or greater
Exclusion Criteria:
1. Patients conditions not meeting the inclusion criteria of NIDDK
2. Patients with Hunner's ulcer
3. Patients with active urinary tract infection
4. Patients who cannot keep a 3-day voiding diary prior to treatment
5. Patients who do not sign informed consent form
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bladder Pain Syndrome
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Intervention(s)
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Drug: intravesical onabotulinumtoxinA injection
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Primary Outcome(s)
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Reduction of bladder pain visual analog scale (VAS)
[Time Frame: baseline to 8 weeks]
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Secondary Outcome(s)
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Maximum flow rate (Qmax)
[Time Frame: baseline to 8 weeks]
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Functional bladder capacity
[Time Frame: baseline to 8 weeks]
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Interstitial cystitis symptom index (ICSI)
[Time Frame: baseline to 8 weeks]
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Interstitial cystitis problem index (ICPI)
[Time Frame: baseline to 8 weeks]
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Postvoid residual volume
[Time Frame: baseline to 8 weeks]
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Voided volume
[Time Frame: baseline to 8 weeks]
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Secondary ID(s)
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BuddhistTCGH2003-01
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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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