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: |
NCT03104361 |
Date of registration:
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03/04/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Platelet-Rich Plasma (PRP) Injection in Treatment of Interstitial Cystitis
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Scientific title:
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Intravesical Injections of Platelet-Rich Plasma (PRP) in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Clinical Trial |
Date of first enrolment:
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April 2017 |
Target sample size:
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30 |
Recruitment status: |
Not yet recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03104361 |
Study type:
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Interventional |
Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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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 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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Email:
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Affiliation:
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Department of Urology, Buddhist TzuChi General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adults with age of 20 years old or above
2. Patients with symptoms of frequency, urgency, nocturia, and/or bladder pain.
3. Proven to have glomerulations (at least grade 2) by cystoscopic hydrodistention under
anesthesia in recent 1 year
4. Free of active urinary tract infection
5. Free of bladder outlet obstruction on enrolment
6. Free of overt neurogenic bladder dysfunction and limitation of ambulation
7. Patient or his/her legally acceptable representative has signed the written informed
consent form
Exclusion Criteria:
1. Hunner's lesion proven by cystoscopy
2. Patients with severe cardiopulmonary disease and such as congestive heart failure,
arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
3. Patients with bladder outlet obstruction on enrollment
4. Patients with postvoid residual >250ml
5. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
6. Patients have laboratory abnormalities at screening including: ALT> 3 x upper limit of
normal range, AST> 3 x upper limit of normal range; Patients have abnormal serum
creatinine level > 2 x upper limit of normal range
7. Patients with any contraindication to be urethral catheterization during treatment
8. Female patients who is pregnant, lactating, or with child-bearing potential without
contraception.
9. Patients with any other serious disease considered by the investigator not in the
condition to enter the trial
10. Patient had received intravesical onabotulinumtoxinA treatment for IC within recent 3
months
11. Patients participated investigational drug trial within 1 month before entering this
study
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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Biological: Platelet-Rich Plasma
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Primary Outcome(s)
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O'Leary-Sant Symptom Score
[Time Frame: from baseline to 1 month after the first treatment day]
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Secondary Outcome(s)
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Voiding frequency
[Time Frame: from baseline to 6 months after the treatment day]
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Visual analog score (VAS) for pain
[Time Frame: from baseline to 6 months after the treatment day]
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Functional bladder capacity (FBC)
[Time Frame: from baseline to 6 months after the treatment day]
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Secondary ID(s)
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TCGH10548A
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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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