Platelet Enriched Plasma for Treatment of Interstitial Cystitis

NCT ID: NCT04118946

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2020-09-30

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 .

Detailed Description

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Conditions

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Interstitial Cystitis Bladder Pain Syndrome Platelet Enriched Plasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with diagnosis of Interstitial cystitis/ Bladder pain syndrome
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravesical instillation

Intravesical instillation of platelet enriched plasma every week for 6 weeks

Group Type ACTIVE_COMPARATOR

platelet enriched plasma

Intervention Type BIOLOGICAL

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.

submucosal injection

submucosal injectionof platelet enriched plasma

Group Type ACTIVE_COMPARATOR

platelet enriched plasma

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Sobhy Elhefnawy

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed El Hefnawy, Msc, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of urology .Mansoura Urology and Nephrology Center

Locations

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Ahmed S EL Hefnawy

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed S El Hefnawy, MD

Role: CONTACT

01224285870

Mohamed Attia

Role: CONTACT

00201090988587

Facility Contacts

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Ahmed El Hefnay, MD

Role: primary

00201224285870

Mohammed Attya

Role: backup

00201090988587

Other Identifiers

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MS.19.03.540

Identifier Type: -

Identifier Source: org_study_id

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