Platelet Enriched Plasma for Treatment of Interstitial Cystitis

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04118946
• Other study ID #: MS.19.03.540
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 20, 2019
• Est. completion date: September 2020

Study information

• Verified date: October 2019
• Source: Mansoura University
• Contact: Ahmed S El Hefnawy, MD
• Phone: 01224285870
• Email: a_s_elhefnawy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Platelet Enriched Plasma
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ahmed S EL Hefnawy	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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