Platelet Enriched Plasma for Treatment of Interstitial Cystitis

Intra Vesical Instillation Versus Submucosal Injection of Platelet Enriched Plasma for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: A Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Interstitial Cystitis; Bladder Pain Syndrome; Platelet Enriched Plasma
• Intervention / Treatment: Biological: platelet enriched plasma

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ahmed S El Hefnawy, MD; Phone Number: 01224285870; Email: a_s_elhefnawy@yahoo.com
• Study Contact Backup: Name: Mohamed Attia; Phone Number: 00201090988587; Email: drmohamedattya4@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • Ahmed S EL Hefnawy
    • Contact: Ahmed El Hefnay, MD; Phone Number: 00201224285870; Email: a_s_elhefnawy@yahoo.com
    • Contact: Mohammed Attya; Phone Number: 00201090988587; Email: drmohamedattya4@gmail.com
    • Sub-Investigator: Nasr El TAbey, MD
    • Sub-Investigator: Mohamed Abd El razik, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intravesical instillation; Intravesical instillation of platelet enriched plasma every week for 6 weeks	Biological: platelet enriched plasma; 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.
Active Comparator: submucosal injection; submucosal injectionof platelet enriched plasma	Biological: platelet enriched plasma; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ahmed El Hefnawy, Msc, MD, Assistant professor of urology .Mansoura Urology and Nephrology Center

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 5, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 5, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease; Syndrome; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: MS.19.03.540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No