Back to resultsPlatelet Enriched Plasma for Treatment of Interstitial Cystitis
Primary Purpose
Interstitial Cystitis, Bladder Pain Syndrome, Platelet Enriched Plasma
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
platelet enriched plasma
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis
Eligibility Criteria
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.
Sites / Locations
- Ahmed S EL HefnawyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
intravesical instillation
submucosal injection
Arm Description
Intravesical instillation of platelet enriched plasma every week for 6 weeks
submucosal injectionof platelet enriched plasma
Outcomes
Primary Outcome Measures
efficacy as measured by global response assessment "GRA"
It will be measured by global response assessment as main tool. Other measurable outcomes including visual analogue scale for pain, Interstitial Cystitis Symptom Index (4 questions) and Problem Index (4 questions) (ICSI/ICPI). These measures will be collected after each session during period of administration of treatment then at 3 months after end of treatment
Secondary Outcome Measures
safety : rate of complication and grade of complications graded by Dindo-Clavien classification
patients will be asked and observed for any anticipated adverse events as hematuria, dysurea, any drug reaction. They will be kept for observation in hospital for 4 hours after delivery for treatment. Periodic reporting of any adverse event by phone call or during next visit.
incidence of urinary tract infection and gynecological infection among this group
by doing urine analysis+/- culture if indicated. By doing vaginal swap for culture if indicated
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04118946
Brief Title
Platelet Enriched Plasma for Treatment of Interstitial Cystitis
Official Title
Intra Vesical Instillation Versus Submucosal Injection of Platelet Enriched Plasma for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective randomized trial will be conducted aiming at evaluation the efficacy and safety of platelet enriched plasma for management of bladder pain syndrome .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome, Platelet Enriched Plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients with diagnosis of Interstitial cystitis/ Bladder pain syndrome
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intravesical instillation
Arm Type
Active Comparator
Arm Description
Intravesical instillation of platelet enriched plasma every week for 6 weeks
Arm Title
submucosal injection
Arm Type
Active Comparator
Arm Description
submucosal injectionof platelet enriched plasma
Intervention Type
Biological
Intervention Name(s)
platelet enriched plasma
Intervention Description
PRP is prepared via a two-step centrifugation preparation of a blood sample, which is cured with an anticoagulant. Then either with be applied through urethral catheter in one arm or via submucos injection in anther one.
Primary Outcome Measure Information:
Title
efficacy as measured by global response assessment "GRA"
Description
It will be measured by global response assessment as main tool. Other measurable outcomes including visual analogue scale for pain, Interstitial Cystitis Symptom Index (4 questions) and Problem Index (4 questions) (ICSI/ICPI). These measures will be collected after each session during period of administration of treatment then at 3 months after end of treatment
Time Frame
3 month for each case. Expected time about 18-24 months for whole study period
Secondary Outcome Measure Information:
Title
safety : rate of complication and grade of complications graded by Dindo-Clavien classification
Description
patients will be asked and observed for any anticipated adverse events as hematuria, dysurea, any drug reaction. They will be kept for observation in hospital for 4 hours after delivery for treatment. Periodic reporting of any adverse event by phone call or during next visit.
Time Frame
3 month for each case. Expected time about 18-24 months for whole study period
Title
incidence of urinary tract infection and gynecological infection among this group
Description
by doing urine analysis+/- culture if indicated. By doing vaginal swap for culture if indicated
Time Frame
3 month for each case. Expected time about 18-24 months for whole study period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed S El Hefnawy, MD
Phone
01224285870
Email
a_s_elhefnawy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Attia
Phone
00201090988587
Email
drmohamedattya4@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed El Hefnawy, Msc, MD
Organizational Affiliation
Assistant professor of urology .Mansoura Urology and Nephrology Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed S EL Hefnawy
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed El Hefnay, MD
Phone
00201224285870
Email
a_s_elhefnawy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohammed Attya
Phone
00201090988587
Email
drmohamedattya4@gmail.com
First Name & Middle Initial & Last Name & Degree
Nasr El TAbey, MD
First Name & Middle Initial & Last Name & Degree
Mohamed Abd El razik, Phd
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platelet Enriched Plasma for Treatment of Interstitial Cystitis
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