Interstitial CystitisPhase 1NCT03104361
Platelet-Rich Plasma (PRP) Injection in Treatment of Interstitial Cystitis
A Phase 1 study testing Platelet-Rich Plasma in people with Interstitial Cystitis, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Platelet-Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2017to Jul 2018
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravesical Injections of Platelet-Rich Plasma (PRP) in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Clinical Trial
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.
Read the detailed description
Background: 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.
Aim: 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.
Setting: Department of Urology, Buddhist Tzu Chi General Hospital.
Materials and Methods: A total of 30 patients with IC/PBS who have failed conventional treatments for at least 6 months will be enrolled in this study. A diagnosis of IC/PBS has been established based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention. All patients have been treated with at least two types of treatment modalities including oral PPS, intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed. All patients should have IC symptoms for at least 6 months, and proven to have grade 1 diffused glomerulations after cystoscopic hydrodistention (HD) within recent 1 year without Hunner's lesion. Eligible patients will be admitted for the treatment. The patients will receive intravesical injection of 12ml PRP (extracted from 50ml of patient's own whole blood) followed by cystoscopic hydrodistention under intravenous general anesthesia in the operation room. The procedure will repeat every one month for a total of four treatments. Blood (10ml) and urine samples (30ml) will be collected before intravesical PRP injection and at 4, 12 and 24 weeks after PRP injection.
Assessment: Primary end-point is the change of the O'Leary-Sant symptom score (including ICSI and ICPI) from baseline to 6 months after the first treatment day. Secondary endpoints include VAS, daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, vided volume, PVR and global response assessment (GRA). Four visits are required at baseline screening (before first treatment) (V1), 1 month after the first treatment (V2, primary end-point), 4 weeks after the fourth treatment (V3), 24 weeks after the first treatment (V4, secondary end-point).
Urine samples will be collected at each time-point for NGF and cytokines tests. Bladder biopsy will be performed at baseline and 6 months after the first treatment day if possible.
Adverse events including UTI, AUR, large PVR (>150ml), dysuria and micturition pain will be recorded
- Conditions
- Interstitial Cystitis
- Being tested
- Platelet-Rich Plasma
- Keywords
- intersitial cystitis, Bladder pain syndrome, Intravesical treatment
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich PlasmaBiological
Also called PRP
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
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich plasma treatment arm | Experimental | 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 Receives: Biological: Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
O'Leary-Sant Symptom Score
- Change of the O'Leary-Sant symptom score (including IC symptom index, ICSI, and IC problem index, ICPI)
Measured: from baseline to 1 month after the first treatment day
Secondary outcomes (3)
Visual analog score (VAS) for pain
Net change of the Visual analog score (VAS) for pain (from 0 to 10)
Measured: from baseline to 6 months after the treatment day
Functional bladder capacity (FBC)
Net change of functional bladder capacity
Measured: from baseline to 6 months after the treatment day
Voiding frequency
Net change of voiding frequency at daytime and voiding frequency at night time as record in 3-day voiding diary
Measured: from baseline to 6 months after the treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startApr 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (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 Interstitial CystitisStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intravesicai injection of platelet-rich plasma
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
- Investigators
- Hann-Chorng kuo, M.D, Principal investigator, Department of Urology, Buddhist TzuChi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104361
- Sponsor's protocol ID
- TCGH10548A
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data with other researchers
Publications
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.
PubMed 32939046
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Injections of Platelet-Rich Plasma (PRP) in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Clinical Trial
- ClinicalTrials.gov ID
- NCT03104361
- Acronym / sponsor ID
- TCGH10548A
- Conditions
- Interstitial Cystitis
- Keywords
- intersitial cystitis, Bladder pain syndrome, Intravesical treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Apr 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 7 Apr 2017 (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.
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.
Detailed description
Background: 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.
Aim: 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.
Setting: Department of Urology, Buddhist Tzu Chi General Hospital.
Materials and Methods: A total of 30 patients with IC/PBS who have failed conventional treatments for at least 6 months will be enrolled in this study. A diagnosis of IC/PBS has been established based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention. All patients have been treated with at least two types of treatment modalities including oral PPS, intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed. All patients should have IC symptoms for at least 6 months, and proven to have grade 1 diffused glomerulations after cystoscopic hydrodistention (HD) within recent 1 year without Hunner's lesion. Eligible patients will be admitted for the treatment. The patients will receive intravesical injection of 12ml PRP (extracted from 50ml of patient's own whole blood) followed by cystoscopic hydrodistention under intravenous general anesthesia in the operation room. The procedure will repeat every one month for a total of four treatments. Blood (10ml) and urine samples (30ml) will be collected before intravesical PRP injection and at 4, 12 and 24 weeks after PRP injection.
Assessment: Primary end-point is the change of the O'Leary-Sant symptom score (including ICSI and ICPI) from baseline to 6 months after the first treatment day. Secondary endpoints include VAS, daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, vided volume, PVR and global response assessment (GRA). Four visits are required at baseline screening (before first treatment) (V1), 1 month after the first treatment (V2, primary end-point), 4 weeks after the fourth treatment (V3), 24 weeks after the first treatment (V4, secondary end-point).
Urine samples will be collected at each time-point for NGF and cytokines tests. Bladder biopsy will be performed at baseline and 6 months after the first treatment day if possible.
Adverse events including UTI, AUR, large PVR (>150ml), dysuria and micturition pain will be recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intravesicai injection of platelet-rich plasma
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma treatment arm | Experimental | Biological: Platelet-Rich PlasmaPatients 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Platelet-Rich PlasmaAlso: PRPPatients 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 | Biological | Platelet-rich plasma treatment arm |
Primary outcome
O'Leary-Sant Symptom Score
Time frame: from baseline to 1 month after the first treatment day
1. Change of the O'Leary-Sant symptom score (including IC symptom index, ICSI, and IC problem index, ICPI)
3 secondary outcomes
Visual analog score (VAS) for pain
Time frame: from baseline to 6 months after the treatment day
Functional bladder capacity (FBC)
Time frame: from baseline to 6 months after the treatment day
Voiding frequency
Time frame: from baseline to 6 months 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 7 Apr 2017.
- Derived from this study: PubMed 32939046Jiang 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.
- Individual participant dataSharing planned: No. No plan to share data with other researchers
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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.
Hann-Chorng kuo, M.D principal investigator
Department of Urology, Buddhist TzuChi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Platelet-Rich Plasma in people with Interstitial Cystitis, run by Buddhist 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 7 inclusion and 11 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 7 Apr 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hann-Chorng Kuo, M.D. (886-3-8561825 ext. 2113, hck@tzuchi.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
O'Leary-Sant Symptom Score (time frame: from baseline to 1 month after the first treatment day). 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 NCT03104361, 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 7 Apr 2017.