Interstitial CystitisPhase 2NCT05275647
Efficacy and Safety of Low Energy Shock Wave Plus BotulinumToxin A in Treating Patients With Interstitial Cystitis
A Phase 2 study testing BOTOX 100U in normal saline and Normal saline in people with Interstitial Cystitis, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Low energy shock wave (LESW) is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW treatment has been demonstrated effective in treatment of nonbacterial prostatitis and chronic pelvic pain syndrome. 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?
- BOTOX 100U in normal saline and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 May 2021to Sep 2024
- Phase
- Phase 2
- 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, and bladder pain at full bladder for more than 6 months.
- Proven to have glomerulations (at least grade 1) 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 agrees to sign the written informed consent form
Who cannot join
- Patient's lower urinary tract symptoms can be effectively treated by conventional therapy
- Patient or his/her legally acceptable representative cannot sign the written informed consent form
- Patient cannot complete the consecutive 3- day voiding diary on the visiting day
- Patient had been treated for overactive bladder by enterocystoplasty
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patient has bladder outlet obstruction on enrollment
Show all 15Show fewer
- Patients has post-void 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
- Patient has coagulation disorder
- 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 hyaluronic acid insillation treatment for IC within recent 6 months before enrolment
- Patient had received intravesical onabotulinumtoxinA treatment for IC within recent 12 months before enrolment
- Patients participated investigational drug trial within 1 month before entering this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Buddhist Tzu Chi General Hospital
Hualien City, 970
Hann-Chorng Kuo, M.D., 886-3-8561825 ext. 2113, hck@tzuchi.com.tw
Shu-Hui Liu, 886-3-8561825 ext. 2117, sa0983655492@gmail.com
About this study
Official title: Therapeutic Efficacy and Safety of Low Energy Shock Wave (LESW) Plus Botulinum Toxin A Instillation in Treatment of Patients With Interstitial Cystitis Refractory to Conventional Therapy - A Clinical and Immunohistochemistry Study
Low energy shock wave (LESW) is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW treatment has been demonstrated effective in treatment of nonbacterial prostatitis and chronic pelvic pain syndrome. LESW reduced pain behavior and down-regulated the NGF expression, suppressed bladder overactivity by decreasing inflammation, IL-6 and COX2 expression and NGF expression. Previous rat interstitial cystitis (IC) models have shown LESW could increase urothelial permeability, facilitate intravesical botulinum toxin A (BoNT-A) delivery and block acetic acid induced hyperactive bladder, suggesting LESW might be a potential therapeutic candidate for relieving bladder inflammatory conditions and overactivity. A double-blind, randomized, placebo-controlled physician-initiated study revealed LESW treatment was associated with a statistically significant decrease in O'Leary-Saint Symptom Score and visual analog scale of pain in patients with interstitial cystitis/bladder pain syndrome (IC/BPS), but the improvement was not superior to the sham LESW treatment. Previous studies found the urothelial dysfunction and deficits of cell differentiation are fundamental pathophysiology of IC/BPS. Through intravesical platelet-rich plasma injections, the chronic inflammation in IC/BPS bladders could be reduced and improved cell differentiation of urothelium. Botox injection or liposome encapsulated Botox could also inhibit inflammation and improve IC/BPS symptoms. However, the Botox injection needs anesthesia and certain complications might occur. There is no study to test if LESW plus Botox intravesical instillation could improve bladder inflammation and relieve IC/BPS symptoms. This study aims to investigate the therapeutic efficacy and safety of concomitant LESW plus intravesical BoNT-A instillation for IC/BPS refractory to conventional treatments.
Read the detailed description
Interstitial cystitis/ bladder pain syndrome (IC/BPS) is a bladder disorder with unknown etiology and difficult treatment. Novel treatments have been searched to adequately improved symptoms. Low energy shock wave (LESW) increased urothelial permeability, facilitated intravesical botulinum toxin A (BoNT-A) delivery and blocked acetic acid induced hyperactive bladder. Rats that received BoNT-A plus LESW showed a significantly reduced response (48.6% decreased intercontractile interval) to acetic acid instillation without compromising voiding function. Rats pre-treated with BoNT-A plus LESW showed a decreased inflammatory reaction (p <0.05), and decreased expressions of SNAP-23 (p < 0.05), SNAP-25 (p = 0.061) and COX-2 (p < 0.05) compared with the control group. These results support LESW as a promising method to deliver BoNT-A across urothelium without the need for injection. LESW is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW treatment reduced pain behavior and down-regulated the NGF expression (33.3%, P < 0.05) on day 4 and IL-6 (40.9%, P < 0.05). LESW treatment suppressed bladder overactivity (intercontractile interval 77.8% increase, P < 0.05) by decreasing inflammation and COX2 (38.6%, P < 0.05) expression and NGF expression (25.2%, P = 0.0812). Previous study revealed that LESW might be a potential candidate for relieving bladder inflammatory conditions and overactivity. Recent clinical trial also revealed that Intravesical instillation of BoNT-A and LESW is a safe and effective method for the treatment of refractory overactive bladder with a durable response for 2 months. A double-blind, randomized, placebo-controlled physician-initiated study enrolled 54 patients with IC/BPS. The patients were assigned to LESW or placebo. At 4 weeks post-treatment, both groups were associated with a statistically significant decrease in OSS and VAS pain scale. A significantly higher proportion of patients on LESW responded as improved in the VAS ≥ 3 vs placebo (P = 0.035). At 12 weeks post-treatment, improvement in the VAS ≥ 3 was 57.1% vs 19.0% (LESW vs placebo; P = 0.011). No significant adverse events were found in either group. This study aims to investigate the therapeutic efficacy and safety of concomitant LESW plus intravesical BoNT-A instillation for IC/BPS patients refractory to conventional treatments.
Materials and Methods
Eligible participants of either gender with IC/BPS refractory to at least two treatments will be enrolled to this study. Participants are randomly allocated to receive either treatment in 1:1 ratio according to the permuted block randomization code as the following:
(A) LESW treatment with 3000 shocks, and followed by intravesical instillation of 30ml normal saline. (placebo group)
(B) LESW with 3000 shocks, and followed by intravesical BoNT-A 100U instillation. (treatment group)
Urine samples will be collected for urinary protein and biomarkers analysis.
- Conditions
- Interstitial Cystitis
- Being tested
- BOTOX 100U in normal saline, Normal saline
- Keywords
- Low energy shock wave, interstitial cystitis, botulinum toxin A, urothelium
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOX 100U in normal salineDrug
Also called BOTOX
LESW with 3000 shocks, frequency of 3 pulses per second, and maximum total energy flow density 0.25 mJ/mm2 , and followed by intravesical BoNT-A 100U instillation in 30ml normal saline retained in the bladder for 2 hours, every one week for 4 times.
Normal salineDrug
Also called Saline
LESW treatment with 3000 shocks, frequency of 3 pulses per second, and maximum total energy flow density 0.25 mJ/mm2 , and followed by intravesical instillation of 30ml normal saline retained in the bladder for 2 hours after LESW application, every one week for 4 times.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group : BoNT-A 100 U in Normal saline | Experimental | BOTOX 100U in normal saline (BoNT-A/NS) 30ml in single intravesical instillation Receives: Drug: BOTOX 100U in normal saline |
| Placebo group : Normal saline | Placebo comparator | Normal saline (N/S) 30ml in single intravesical instillation Receives: Drug: Normal saline |
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 Interstitial Cystitis Symptom Index from 0 to 10 points and Interstitial Cystitis Problem Index, from 0 to 20 points; a higher score indicates a worse symptom severity)
Measured: from baseline to 3 month after the treatment day
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Local or systemic adverse events such as hematuria, miction pain, difficult urination, or any systemic symptoms such as fever, general weakness, dyspnea, etc.)
Measured: from baseline to 3 month after the treatment day
Secondary outcomes (14)
Global response assessment (GRA)
Global response assessment (GRA) of satisfaction by the patient (categorized into -3, -2, -1, 0, 1, 2, 3 units of scale, indicating markedly worse to markedly improved) at 1 month after the treatment day.
An improvement of GRA by 2 units of scale at 1 month is considered effective.
Measured: 1 month after the treatment day
Visual analog score (VAS) for pain
Net change of the Visual analog score (VAS) for pain (from 0 to 10 units of scale, indicating no pain (0) to severe pain (10))
Measured: from baseline to 1 month and 3 months after the first treatment day
Functional bladder capacity
Net change of functional bladder capacity (FBC, in milliliter)
Measured: from baseline to 1 month and 3 months after the first treatment day
Voiding frequency per day
Net change of voiding frequency at daytime and voiding frequency at night time as record in 3-day voiding diary
Measured: from baseline to 1 month and 3 months after the first treatment day
maximum flow rate
Net changes of the maximum flow rate (Qmax, in milliliter/second)
Measured: from baseline to 1 month after the first treatment day
voided volume
Net changes of the voided volume (in milliliter)
Measured: from baseline to 1 month after the first treatment day
Pos-tvoid residual volume (PVR)
Net changes of the PVR (in milliliter)
Measured: from baseline to 1 month after the first treatment day
urinary nerve growth factor (NGF)
Changes of urinary NGF level in urine (in nanogram/milliliter)
Measured: from baseline to 1 month and 3 months after the first treatment day
urinary brain derived neurotrophic factor (BDNF)
Changes of urinary BDNF (in nanogram/milliliter)
Measured: from baseline to 1 month and 3 months after the first treatment day
Inflammatory cytokine IL-2 level
Changes of cytokine IL-2 level (in nanogram/milliliter)
Measured: from baseline to 1 month and 3 months after the first treatment day
Inflammatory cytokines IL-6 level
Changes of cytokines IL-6 level (in nanogram/milliliter)
Measured: from baseline to 1 month and 3 months after the first treatment day
Inflammatory cytokine IL-8 level
Changes of cytokine IL-8 level (in nanogram/milliliter)
Measured: from baseline to 1 month and 3 months after the first treatment day
Inflammatory cytokine IL-1 beta level
Changes of cytokine IL-1 beta level (in nanogram/milliliter)
Measured: from baseline to 1 month and 3 months after the first treatment day
Safety outcome (Local and systemic adverse events)
Any adverse events occurring after treatment, including hematuria, micturition pain, difficulty in urination, urinary tract infection, or systemic symptoms
Measured: from baseline to 1 month and 3 months after the first treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start18 May 2021
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, randomized, placebo-controlled physician initiated study enrolled patients with refractory IC/BPS.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, Hualien Tzu Chi General Hospital
- Responsible party
- Principal investigator, Hann-Chorng Kuo, M.D., 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
- NCT05275647
- Sponsor's protocol ID
- IRB 110-078-A
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy and Safety of Low Energy Shock Wave (LESW) Plus Botulinum Toxin A Instillation in Treatment of Patients With Interstitial Cystitis Refractory to Conventional Therapy - A Clinical and Immunohistochemistry Study
- ClinicalTrials.gov ID
- NCT05275647
- Acronym / sponsor ID
- IRB 110-078-A
- Conditions
- Interstitial Cystitis
- Keywords
- Low energy shock wave, interstitial cystitis, botulinum toxin A, urothelium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, Hualien Tzu Chi General Hospital
- Study start
- 18 May 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 Mar 2022 (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.
Low energy shock wave (LESW) is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW treatment has been demonstrated effective in treatment of nonbacterial prostatitis and chronic pelvic pain syndrome. LESW reduced pain behavior and down-regulated the NGF expression, suppressed bladder overactivity by decreasing inflammation, IL-6 and COX2 expression and NGF expression. Previous rat interstitial cystitis (IC) models have shown LESW could increase urothelial permeability, facilitate intravesical botulinum toxin A (BoNT-A) delivery and block acetic acid induced hyperactive bladder, suggesting LESW might be a potential therapeutic candidate for relieving bladder inflammatory conditions and overactivity. A double-blind, randomized, placebo-controlled physician-initiated study revealed LESW treatment was associated with a statistically significant decrease in O'Leary-Saint Symptom Score and visual analog scale of pain in patients with interstitial cystitis/bladder pain syndrome (IC/BPS), but the improvement was not superior to the sham LESW treatment. Previous studies found the urothelial dysfunction and deficits of cell differentiation are fundamental pathophysiology of IC/BPS. Through intravesical platelet-rich plasma injections, the chronic inflammation in IC/BPS bladders could be reduced and improved cell differentiation of urothelium. Botox injection or liposome encapsulated Botox could also inhibit inflammation and improve IC/BPS symptoms. However, the Botox injection needs anesthesia and certain complications might occur. There is no study to test if LESW plus Botox intravesical instillation could improve bladder inflammation and relieve IC/BPS symptoms. This study aims to investigate the therapeutic efficacy and safety of concomitant LESW plus intravesical BoNT-A instillation for IC/BPS refractory to conventional treatments.
Detailed description
Interstitial cystitis/ bladder pain syndrome (IC/BPS) is a bladder disorder with unknown etiology and difficult treatment. Novel treatments have been searched to adequately improved symptoms. Low energy shock wave (LESW) increased urothelial permeability, facilitated intravesical botulinum toxin A (BoNT-A) delivery and blocked acetic acid induced hyperactive bladder. Rats that received BoNT-A plus LESW showed a significantly reduced response (48.6% decreased intercontractile interval) to acetic acid instillation without compromising voiding function. Rats pre-treated with BoNT-A plus LESW showed a decreased inflammatory reaction (p <0.05), and decreased expressions of SNAP-23 (p < 0.05), SNAP-25 (p = 0.061) and COX-2 (p < 0.05) compared with the control group. These results support LESW as a promising method to deliver BoNT-A across urothelium without the need for injection. LESW is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW treatment reduced pain behavior and down-regulated the NGF expression (33.3%, P < 0.05) on day 4 and IL-6 (40.9%, P < 0.05). LESW treatment suppressed bladder overactivity (intercontractile interval 77.8% increase, P < 0.05) by decreasing inflammation and COX2 (38.6%, P < 0.05) expression and NGF expression (25.2%, P = 0.0812). Previous study revealed that LESW might be a potential candidate for relieving bladder inflammatory conditions and overactivity. Recent clinical trial also revealed that Intravesical instillation of BoNT-A and LESW is a safe and effective method for the treatment of refractory overactive bladder with a durable response for 2 months. A double-blind, randomized, placebo-controlled physician-initiated study enrolled 54 patients with IC/BPS. The patients were assigned to LESW or placebo. At 4 weeks post-treatment, both groups were associated with a statistically significant decrease in OSS and VAS pain scale. A significantly higher proportion of patients on LESW responded as improved in the VAS ≥ 3 vs placebo (P = 0.035). At 12 weeks post-treatment, improvement in the VAS ≥ 3 was 57.1% vs 19.0% (LESW vs placebo; P = 0.011). No significant adverse events were found in either group. This study aims to investigate the therapeutic efficacy and safety of concomitant LESW plus intravesical BoNT-A instillation for IC/BPS patients refractory to conventional treatments.
Materials and Methods
Eligible participants of either gender with IC/BPS refractory to at least two treatments will be enrolled to this study. Participants are randomly allocated to receive either treatment in 1:1 ratio according to the permuted block randomization code as the following:
(A) LESW treatment with 3000 shocks, and followed by intravesical instillation of 30ml normal saline. (placebo group)
(B) LESW with 3000 shocks, and followed by intravesical BoNT-A 100U instillation. (treatment group)
Urine samples will be collected for urinary protein and biomarkers analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, randomized, placebo-controlled physician initiated study enrolled patients with refractory IC/BPS.
| Arm | Type | Receives |
|---|---|---|
| Treatment group : BoNT-A 100 U in Normal saline | Experimental | Drug: BOTOX 100U in normal salineBOTOX 100U in normal saline (BoNT-A/NS) 30ml in single intravesical instillation |
| Placebo group : Normal saline | Placebo comparator | Drug: Normal salineNormal saline (N/S) 30ml in single intravesical instillation |
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, and bladder pain at full bladder for more than 6 months.
- Proven to have glomerulations (at least grade 1) 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 (15 listed)
- Patient's lower urinary tract symptoms can be effectively treated by conventional therapy
- Patient or his/her legally acceptable representative cannot sign the written informed consent form
- Patient cannot complete the consecutive 3- day voiding diary on the visiting day
- Patient had been treated for overactive bladder by enterocystoplasty
- 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 |
|---|---|---|
| BOTOX 100U in normal salineAlso: BOTOXLESW with 3000 shocks, frequency of 3 pulses per second, and maximum total energy flow density 0.25 mJ/mm2 , and followed by intravesical BoNT-A 100U instillation in 30ml normal saline retained in the bladder for 2 hours, every one week for 4 times. | Drug | Treatment group : BoNT-A 100 U in Normal saline |
| Normal salineAlso: SalineLESW treatment with 3000 shocks, frequency of 3 pulses per second, and maximum total energy flow density 0.25 mJ/mm2 , and followed by intravesical instillation of 30ml normal saline retained in the bladder for 2 hours after LESW application, every one week for 4 times. | Drug | Placebo group : Normal saline |
Primary outcome
O'Leary-Sant Symptom Score
Time frame: from baseline to 3 month after the treatment day
Change of the O'Leary-Sant symptom score (including Interstitial Cystitis Symptom Index from 0 to 10 points and Interstitial Cystitis Problem Index, from 0 to 20 points; a higher score indicates a worse symptom severity)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: from baseline to 3 month after the treatment day
Local or systemic adverse events such as hematuria, miction pain, difficult urination, or any systemic symptoms such as fever, general weakness, dyspnea, etc.)
14 secondary outcomes
Global response assessment (GRA)
Time frame: 1 month after the treatment day
Visual analog score (VAS) for pain
Time frame: from baseline to 1 month and 3 months after the first treatment day
Functional bladder capacity
Time frame: from baseline to 1 month and 3 months after the first treatment day
Voiding frequency per day
Time frame: from baseline to 1 month and 3 months after the first treatment day
maximum flow rate
Time frame: from baseline to 1 month after the first treatment day
voided volume
Time frame: from baseline to 1 month after the first treatment day
Pos-tvoid residual volume (PVR)
Time frame: from baseline to 1 month after the first treatment day
urinary nerve growth factor (NGF)
Time frame: from baseline to 1 month and 3 months after the first treatment day
urinary brain derived neurotrophic factor (BDNF)
Time frame: from baseline to 1 month and 3 months after the first treatment day
Inflammatory cytokine IL-2 level
Time frame: from baseline to 1 month and 3 months after the first treatment day
Inflammatory cytokines IL-6 level
Time frame: from baseline to 1 month and 3 months after the first treatment day
Inflammatory cytokine IL-8 level
Time frame: from baseline to 1 month and 3 months after the first treatment day
Inflammatory cytokine IL-1 beta level
Time frame: from baseline to 1 month and 3 months after the first treatment day
Safety outcome (Local and systemic adverse events)
Time frame: from baseline to 1 month and 3 months after the first treatment day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: No
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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 2 study testing BOTOX 100U in normal saline and Normal saline 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 15 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 25 Mar 2022. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 month after the treatment day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2022.