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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
PRP
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

Other trials in Taiwan

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.

  1. 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.

  1. First posted1 Apr 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion22 May 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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)
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

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.

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