Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/BladderNCT06339645
Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder-A Retrospective Study
An observational study of Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder, run by Hualien Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitis/bladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of IC/BPS, with age of at least 20-84 years… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder
- What is being tested?
- PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 658 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention
Who may be able to join
- NIDDK criteria diagnostic IC/BPS, and received the intravesical PRP injection before
Who cannot join
- non-IC/BPS patients
- psychological disease was diagnosed
- non-NIDDK criteria (Hunner's ulcer type)
- Under-primary or illiterate respondents
- 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
Show all 13Show fewer
- Patients with post-void residual > 150ml
- Patients with an uncontrolled confirmed diagnosis of acute urinary tract infection
- Patients have laboratory abnormalities at screening
- Patients who cannot used urinary catheter to treat.
- Female patients who are pregnant, lactating, or childbearing potential without contraception.
- Patients with any other serious disease considered by the investigator not in the condition to enter the trial
- Patients cannot record the voiding diary
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Wan Ru Yu
Hualien City, Outside U.S./Taiwan, 970
Wan Ru Yu, 0925051013, wanzu666@gmail.com
About this study
Official title: The Correlation of Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder-A Retrospective Study
The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitis/bladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of IC/BPS, with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention. Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection.
Read the detailed description
Introduction: Interstitial cystitis/bladder pain syndrome (IC/BPS) 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 IC/BPS 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 patient's 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 patient's 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 IC/BPS. 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 IC/BPS. 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 IC/BPS from 2016/1/1 to 2023/10/21. 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.
- Being tested
- PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPProcedure or surgery
Patients who meet all eligibility requirements for entry into the study of intravesical PRP injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Global response assessment (GRA)
satisfaction by the patient (categorized into -3, -2,-1, 0, +1, +2, +3, indicating markedly worse to markedly improved ) after the treatment day
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion22 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hualien Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Ru Yu, Hualien Tzu Chi General Hospital
- Investigators
- Wan Ru Yu, Principal investigator, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339645
- Sponsor's protocol ID
- P00003121
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu WR, Kuo HC. Functional bladder capacity can reflect the bladder condition and treatment outcome in patients with interstitial cystitis/bladder pain syndrome. World J Urol. 2026 Jan 17;44(1):101. doi: 10.1007/s00345-025-05937-2.
PubMed 41546691
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder-A Retrospective Study
- ClinicalTrials.gov ID
- NCT06339645
- Acronym / sponsor ID
- P00003121
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 658 participants (estimated)
- Lead sponsor
- Hualien Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 22 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The correlation of safety and effectiveness between intravesical platelet-rich plasma injection in patients with interstitial cystitis/bladder-A retrospective study to evaluate the correlation of safety and effectiveness between intravesical platelet-rich plasma injection of IC/BPS, with age of at least 20-84 years old in Taiwan of either sex with IC/BPS 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 cystitis/bladder pain syndrome (IC/BPS) 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 IC/BPS 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 patient's 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 patient's 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 IC/BPS. 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 IC/BPS. 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 IC/BPS from 2016/1/1 to 2023/10/21. 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with age of at least 20-84 years old in Taiwan of either sex with IC/BPS symptoms and proven of IC by cystoscopic hydrodistention
Key inclusion criteria (1 listed)
- NIDDK criteria diagnostic IC/BPS, and received the intravesical PRP injection before
Key exclusion criteria (13 listed)
- non-IC/BPS patients
- psychological disease was diagnosed
- non-NIDDK criteria (Hunner's ulcer type)
- Under-primary or illiterate respondents
- patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRPPatients who meet all eligibility requirements for entry into the study of intravesical PRP injection | Procedure or surgery | – |
Primary outcome
Global response assessment (GRA)
Time frame: 6 months
satisfaction by the patient (categorized into -3, -2,-1, 0, +1, +2, +3, indicating markedly worse to markedly improved ) after the treatment day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Derived from this study: PubMed 41546691Yu WR, Kuo HC. Functional bladder capacity can reflect the bladder condition and treatment outcome in patients with interstitial cystitis/bladder pain syndrome. World J Urol. 2026 Jan 17;44(1):101. doi: 10.1007/s00345-025-05937-2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Ru Yu principal investigator
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien, Taiwan,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety and Effectiveness Between Intravesical Platelet-rich Plasma Injection in Patients With Interstitial Cystitis/Bladder, run by Hualien Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan Ru Yu (0925051013, wanzu666@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global response assessment (GRA) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06339645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.