Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339645
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Brief Title:
Intravesical Platelet-rich Plasma Injection in Patients With Interstitial CystitisBladder-A Retrospective Study
Sponsor:
Hualien Tzu Chi General Hospital
Organization:
Hualien Tzu Chi General Hospital
Study Overview
Official Title:
The Correlation of Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial CystitisBladder-A Retrospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitisbladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of ICBPS with age of at least 20-84 years old in Taiwan of either sex with ICBPS symptoms and proven of IC by cystoscopic hydrodistention Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection
Detailed Description:
Introduction Interstitial cystitisbladder pain syndrome ICBPS is a chronic inflammatory disease of the bladder characterized by symptoms such as frequency urgency nocturia and lower abdominal pain Despite being recognized for a hundred years there has not been a definitive treatment method that can completely eliminate bladder inflammation Various methods have been attempted including bladder hydrodistention anti-inflammatory drugs steroid injections and the use of bladder epithelial protectants such as Hyaluronic Acid In recent years the use of intravesical injection of botulinum toxin for the treatment of ICBPS has emerged however none of these methods have achieved the goal of long-term cure Therefore achieving remission of interstitial cystitis has been a persistent goal for urologists
Platelet-rich plasma PRP therapy has emerged as a novel treatment modality in the past one to two decades widely used for degenerative joint diseases and muscle injuries This therapy involves extracting high concentrations of platelets mixed with serum from the patients own blood excluding red and white blood cells and injecting this high-concentration platelet serum into the affected area This exploits the various growth factors and cytokines abundant in platelets to promote wound healing and reduce chronic inflammation PRP has shown promising results in many sports injuries and degenerative joint diseases over the past decade As PRP is derived from the patients own blood it does not induce allergic reactions or produce any side effects
PRP has been previously shown to effectively improve epithelial dysfunction and chronic inflammation in ICBPS We hope PRP injection can gradually eliminate inflammation within the bladder and its various growth factors can facilitate the repair of damaged bladder epithelium If this treatment proves effective it could offer a better therapeutic option for many patients suffering from bladder symptoms due to interstitial cystitis
Several patients have been enrolled since the initiation of clinical trials using intravesical injection of platelet-rich plasma for bladder treatment in 2016 However data collection has been limited to single clinical trial studies PRP has gradually become a routine treatment for patients with ICBPS Therefore this study aims to comprehensively review the medical records of all patients who have received bladder PRP injections to clarify and understand the basic information and clinical examination data of patients with interstitial cystitis who have received bladder PRP injections from the past to the present
Aim This study also aims to understand interstitial cystitis further and investigate the safety and efficacy of bladder PRP injections for patients with interstitial cystitis
Materials and Methods
This retrospective study enrolled the patients who received intravesical PRP injection treatments in patients with ICBPS from 201611 to 20231021 We used the chart review and questionnaire collection analyzed the patients characteristics including age gender IC symptoms and pain severity and also collected anxiety severity all in the chart Also the voiding diary maximum bladder capacity urine biomarkers and glomerulation grade were analyzed
Assessment The patients will be investigated using the chart review for the voiding diary for frequency nocturia episodes per day ICSI IC problem index ICPI Numerical Rating Scale NRS of pain patient perception of bladder condition PPBC global response assessment GRA maximal flow rate Qmax voided volume Vol and post-void residual urine PVR volume measurement at baseline and after treatment Urine samples will also be obtained for urinary biomarkers determination at baseline and after different therapy
Platelet-rich plasma PRP therapy has emerged as a novel treatment modality in the past one to two decades widely used for degenerative joint diseases and muscle injuries This therapy involves extracting high concentrations of platelets mixed with serum from the patients own blood excluding red and white blood cells and injecting this high-concentration platelet serum into the affected area This exploits the various growth factors and cytokines abundant in platelets to promote wound healing and reduce chronic inflammation PRP has shown promising results in many sports injuries and degenerative joint diseases over the past decade As PRP is derived from the patients own blood it does not induce allergic reactions or produce any side effects
PRP has been previously shown to effectively improve epithelial dysfunction and chronic inflammation in ICBPS We hope PRP injection can gradually eliminate inflammation within the bladder and its various growth factors can facilitate the repair of damaged bladder epithelium If this treatment proves effective it could offer a better therapeutic option for many patients suffering from bladder symptoms due to interstitial cystitis
Several patients have been enrolled since the initiation of clinical trials using intravesical injection of platelet-rich plasma for bladder treatment in 2016 However data collection has been limited to single clinical trial studies PRP has gradually become a routine treatment for patients with ICBPS Therefore this study aims to comprehensively review the medical records of all patients who have received bladder PRP injections to clarify and understand the basic information and clinical examination data of patients with interstitial cystitis who have received bladder PRP injections from the past to the present
Aim This study also aims to understand interstitial cystitis further and investigate the safety and efficacy of bladder PRP injections for patients with interstitial cystitis
Materials and Methods
This retrospective study enrolled the patients who received intravesical PRP injection treatments in patients with ICBPS from 201611 to 20231021 We used the chart review and questionnaire collection analyzed the patients characteristics including age gender IC symptoms and pain severity and also collected anxiety severity all in the chart Also the voiding diary maximum bladder capacity urine biomarkers and glomerulation grade were analyzed
Assessment The patients will be investigated using the chart review for the voiding diary for frequency nocturia episodes per day ICSI IC problem index ICPI Numerical Rating Scale NRS of pain patient perception of bladder condition PPBC global response assessment GRA maximal flow rate Qmax voided volume Vol and post-void residual urine PVR volume measurement at baseline and after treatment Urine samples will also be obtained for urinary biomarkers determination at baseline and after different therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None