Platelet Enriched Plasma for Treatment of Interstitial Cystitis

Study Overview
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Brief Summary
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A prospective randomized trial will be conducted aiming at evaluation the efficacy and safety of platelet enriched plasma for management of bladder pain syndrome .

Official 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

Conditions
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Interstitial Cystitis, Bladder Pain Syndrome, Platelet Enriched Plasma

Intervention / Treatment
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* Biological: platelet enriched plasma


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with diagnosis of Interstitial cystitis/ Bladder pain syndrome
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravesical instillation<br>Intravesical instillation of platelet enriched plasma every week for 6 weeks | Biological: platelet enriched plasma<br>* 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.<br>|
| Active Comparator: submucosal injection<br>submucosal injectionof platelet enriched plasma | Biological: platelet enriched plasma<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 month for each case. Expected time about 18-24 months for whole study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 month for each case. Expected time about 18-24 months for whole study period | 
| 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 | 3 month for each case. Expected time about 18-24 months for whole study period |