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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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12 December 2020 |
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Main ID: |
NCT04118946 |
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Date of registration:
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02/10/2019 |
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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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Platelet Enriched Plasma for Treatment of Interstitial Cystitis
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Scientific title:
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Intra Vesical Instillation Versus Submucosal Injection of Platelet Enriched Plasma for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: A Randomized Controlled Trial |
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Date of first enrolment:
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March 20, 2019 |
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Target sample size:
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33 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04118946 |
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Study type:
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Interventional |
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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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Phase 1/Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Ahmed El Hefnawy, Msc, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistant professor of urology .Mansoura Urology and Nephrology Center |
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Name:
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Ahmed S El Hefnawy, MD |
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Address:
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Telephone:
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01224285870 |
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Email:
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a_s_elhefnawy@yahoo.com |
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Affiliation:
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Name:
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Ahmed El Hefnay, MD |
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Address:
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Telephone:
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00201224285870 |
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Email:
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a_s_elhefnawy@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a diagnosis of interstitial cystitis/ Bladder painful Syndrome for more
than 3 months will be enrolled
Exclusion Criteria:
- Patients with Anemia, blood disorders, history of pelvic irradiation, pelvic
malignancy, and active urinary tract infection unless treated, vesical stone,
gynecological disorders e.g. uterine fibroid and neurological disorders will be
excluded. Patients less than 18 years old will not be allowed to participate.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Bladder Pain Syndrome
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Platelet Enriched Plasma
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Interstitial Cystitis
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Intervention(s)
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Biological: platelet enriched plasma
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Primary Outcome(s)
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efficacy as measured by global response assessment "GRA"
[Time Frame: 3 month for each case. Expected time about 18-24 months for whole study period]
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Secondary Outcome(s)
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safety : rate of complication and grade of complications graded by Dindo-Clavien classification
[Time Frame: 3 month for each case. Expected time about 18-24 months for whole study period]
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incidence of urinary tract infection and gynecological infection among this group
[Time Frame: 3 month for each case. Expected time about 18-24 months for whole study period]
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Secondary ID(s)
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MS.19.03.540
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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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