Platelet-Rich Plasma (PRP) Injection in Treatment of Interstitial Cystitis
Intravesical Injections of Platelet-Rich Plasma (PRP) in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Clinical Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating chronic disease of unknown etiology characterized by urgency frequency and suprapubic pain at full bladder. Current treatments are usually unsuccessful in completely eradicating bladder pain and increasing bladder capacity. Autologous platelet-rich plasma (PRP) is growing in popularity as a therapy to augment wound healing, speed the recovery from muscle and joint injuries, and enhance recovery after surgical repair. PRP is extremely rich in growth factors and cytokines, which regulate tissue reconstruction and has been studied extensively among trauma patients and trauma experimental models. Tissue regeneration can be improved by local application of autologous bone marrow derived progenitor cells and PRP. This clinical trial attempts to use autologous PRP in treatment of interstitial cystitis refractory to currently available medical treatment or intravesical therapy. The results of this study might provide clinical evidence for a novel therapeutic regimen in the treatment of IC/PBS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedApril 7, 2017
April 1, 2017
1.2 years
April 3, 2017
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
O'Leary-Sant Symptom Score
1\. Change of the O'Leary-Sant symptom score (including IC symptom index, ICSI, and IC problem index, ICPI)
from baseline to 1 month after the first treatment day
Secondary Outcomes (3)
Visual analog score (VAS) for pain
from baseline to 6 months after the treatment day
Functional bladder capacity (FBC)
from baseline to 6 months after the treatment day
Voiding frequency
from baseline to 6 months after the treatment day
Study Arms (1)
Platelet-rich plasma treatment arm
EXPERIMENTALPatients who meet all eligible requirements for entry into the study will be treated with intravesical injection of PRP (extracted from 50ml whole blood ) at 20 sites
Interventions
Patients who meet all eligible requirements for entry into the study will be treated with intravesical injection of PRP (extracted from 50ml whole blood ) at 20 sites
Eligibility Criteria
You may qualify if:
- Adults with age of 20 years old or above
- Patients with symptoms of frequency, urgency, nocturia, and/or bladder pain.
- Proven to have glomerulations (at least grade 2) by cystoscopic hydrodistention under anesthesia in recent 1 year
- Free of active urinary tract infection
- Free of bladder outlet obstruction on enrolment
- Free of overt neurogenic bladder dysfunction and limitation of ambulation
- Patient or his/her legally acceptable representative has signed the written informed consent form
You may not qualify if:
- Hunner's lesion proven by cystoscopy
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patients with bladder outlet obstruction on enrollment
- Patients with postvoid residual \>250ml
- Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
- Patients have laboratory abnormalities at screening including: ALT\> 3 x upper limit of normal range, AST\> 3 x upper limit of normal range; Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
- Patients with any contraindication to be urethral catheterization during treatment
- Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
- Patients with any other serious disease considered by the investigator not in the condition to enter the trial
- Patient had received intravesical onabotulinumtoxinA treatment for IC within recent 3 months
- Patients participated investigational drug trial within 1 month before entering this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Buddhist Tzu Chi General Hospital
Hualien City, 970, Taiwan
Related Publications (1)
Jiang YH, Kuo YC, Jhang JF, Lee CL, Hsu YH, Ho HC, Kuo HC. Repeated intravesical injections of platelet-rich plasma improve symptoms and alter urinary functional proteins in patients with refractory interstitial cystitis. Sci Rep. 2020 Sep 16;10(1):15218. doi: 10.1038/s41598-020-72292-0.
PMID: 32939046DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hann-Chorng kuo, M.D
Department of Urology, Buddhist TzuChi General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman, Department of Urology
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 7, 2017
Study Start
April 1, 2017
Primary Completion
June 1, 2018
Study Completion
July 1, 2018
Last Updated
April 7, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share
No plan to share data with other researchers