Platelet Enriched Plasma for Treatment of Interstitial Cystitis

Phase 1

• Conditions: Bladder Pain Syndrome; Interstitial Cystitis; Platelet Enriched Plasma
• Interventions: Biological: platelet enriched plasma

• Registration Number: NCT04118946
• Lead Sponsor: Mansoura University

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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-20
• Status Verified: 2019-10
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-05
• Last Update Submitted: 2019-10-05
• Study First Posted: 2019-10-08
• Last Update Posted: 2019-10-08
• Primary Completion: 2020-06
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Patients with a diagnosis of interstitial cystitis/ Bladder painful Syndrome for more than 3 months will be enrolled

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravesical instillation	platelet enriched plasma	Intravesical instillation of platelet enriched plasma every week for 6 weeks
submucosal injection	platelet enriched plasma	submucosal injectionof platelet enriched plasma

Primary Outcome Measures

Name	Time	Method
efficacy as measured by global response assessment "GRA"	3 month for each case. Expected time about 18-24 months for whole study period	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

Name	Time	Method
safety : rate of complication and grade of complications graded by Dindo-Clavien classification	3 month for each case. Expected time about 18-24 months for whole study period	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	3 month for each case. Expected time about 18-24 months for whole study period	by doing urine analysis+/- culture if indicated. By doing vaginal swap for culture if indicated

Trial Locations

Locations (1)

Ahmed S EL Hefnawy; 🇪🇬 Mansoura, Egypt