Platelet Enriched Plasma for Treatment of Interstitial Cystitis

NCT04118946 | Unknown Phase 1 DMC

• 1 other identifier: MS.19.03.540
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 .

Conditions

Interstitial Cystitis; Bladder Pain Syndrome; Platelet Enriched Plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

intravesical instillation

ACTIVE COMPARATOR

Intravesical instillation of platelet enriched plasma every week for 6 weeks

Biological: platelet enriched plasma

submucosal injection

ACTIVE COMPARATOR

submucosal injectionof platelet enriched plasma

Biological: platelet enriched plasma

Interventions

platelet enriched plasma 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.

intravesical instillation; submucosal injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ahmed S EL Hefnawy

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ahmed El Hefnawy, Msc, MD

  Assistant professor of urology .Mansoura Urology and Nephrology Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed S El Hefnawy, MD

CONTACT

01224285870; a_s_elhefnawy@yahoo.com

Mohamed Attia

CONTACT

00201090988587; drmohamedattya4@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: Patients with diagnosis of Interstitial cystitis/ Bladder pain syndrome

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 8, 2019
• Study Start: March 20, 2019
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)