Interstitial CystitisPhase 2NCT02247557
Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis
A Phase 2 study testing Liposome encapsulated BoNT-A, BOTOX 200U 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
To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Liposome encapsulated BoNT-A, BOTOX 200U in normal saline and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2014to Feb 2017
- 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 to 80 years
- 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 enrollment
- 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
Show all 12Show fewer
- Patients with any contraindication to be urethral catheterization during treatment
- Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
- Myasthenia gravis, Eaton Lambert syndrome.
- Patients with any other serious disease considered by the investigator not in the condition to enter the trial
- Patient had received intravesical treatment for IC within recent 1 month
- 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 Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis - a Randomized, Double-blind, Placebo-controlled, Prospective Study
To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS
Read the detailed description
Liposome has been proven able to carry botulinum toxin protein across the cell membrane and effect on urothelial receptors in human overactive bladder. However, the therapeutic duration is limited to 1 month. Intravesical BOTOX injection in patients with interstitial cystitis (IC) can effectively decrease pain, improve bladder capacity and decrease frequency. However, the need of cystoscopic injection limits its wide application.
A total of 100 eligible women with non-ulcer IC will be enrolled to receive intravesical instillation of Lipotoxin containing 80mg liposomes and 200U BOTOX (treatment group), 200U BOTOX in normal saline (N/S) (active control group) or normal saline (placebo control group) single treatment. At least 90 evaluable patients will be included for the final analysis.
All patients should have IC symptoms for at least 6 months, and proven to have grade 2 diffused glomerulations after cystoscopic hydrodistention (HD) within recent 1 year without Hunner's lesion. Patients should not have UTI in recent 12 months, no urinary tract stone. Patients should have been proven free of detrusor overactivity or bladder outlet obstruction. Patients should not receive intravesical hyaluronic acid treatment in recent 6 months, or intravesical Botox injection in recent 12 months. Intravesical instillation of Lipotoxin at OPD and the patient should hold the solution for 2 hours to allow bladder distention. Retreatment with Lipotoxin at 3 months if patient reports ineffective.
Primary end-point is the change of the O'Leary-Sant symptom score (including ICSI and ICPI) from baseline to 1 month after treatment. Secondary endpoints include VAS, daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, voided volume, PVR and global response assessment (GRA). Four visits are required at baseline screening (before first treatment), treatment (V1), 2 weeks (V2), 4 weeks (V3, primary end-point) and 12 weeks (V4).
- Conditions
- Interstitial Cystitis
- Being tested
- Liposome encapsulated BoNT-A, BOTOX 200U in normal saline, Normal saline
- Keywords
- IC/PBS, VAS, Botulinum Toxin A, Lipotoxin
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome encapsulated BoNT-ADrug
Also called Liposome, onabotulinumtoxinA 200U
Liposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation
BOTOX 200U in normal salineDrug
Also called onabotulinumtoxinA 200U
BOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation
Normal salineDrug
Also called Saline
Normal saline (N/S) 50ml in single intravesical instillation
| Study group | Role | What they receive |
|---|---|---|
| Group A: Liposome encapsulated BoNT-A | Experimental | Liposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation Receives: Drug: Liposome encapsulated BoNT-A |
| Group B: BoNT-A 200 U in Normal saline | Experimental | BOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation Receives: Drug: BOTOX 200U in normal saline |
| Group C: Normal saline | Placebo comparator | Normal saline (N/S) 50ml 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.
Change of the O'Leary-Sant symptom score
Change of the O'Leary-Sant symptom score from baseline to 1 month after the treatment day
Measured: Baseline and 1 month
Secondary outcomes (10)
Net changes of the Visual Analog Scale (VAS)
Net changes of the Visual Analog Scale from baseline to 1 month after the treatment day
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net changes of the functional bladder capacity (FBC)
Net changes of the functional bladder capacity from baseline to 1 month after the treatment day
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary
Net changes of the voiding frequency at daytime from baseline to 1 month after the treatment day
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary
Net changes of the voiding night time from baseline to 1 month after the treatment day
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net Change of the Global response assessment (GRA)
Global response assessment (GRA) of therapeutic result by the patient (categorized from -3 to +3, indicating markedly worse to markedly improved) at 3 months after the treatment day.
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net Change of the maximum flow rate
Net changes of the maximum flow rate from baseline to 1 month after the treatment day.
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net Change of the voided volume
Net changes of the voided volume from baseline to 1 month after the treatment day.
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net Change of the PVR
Net changes of the PVR from baseline to 1 month after the treatment day.
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net Change of the urinary nerve growth factor
Changes of urinary nerve growth factor from baseline to 1 month after treatment day.
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Net Change of the cytokines level
Changes of cytokines level from baseline to 1 month after treatment day.
Safety
(1) Local adverse event incidences (hematuria, miction pain, UTI, urinary retention).
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2017
- Study completionFeb 2017
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 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. Patients were assigned to intravesical instillation of lipotoxin (onabotulinumtoxinA 200 U with 80mg sphingomyelin), onabotulinumtoxinA 200 U in normal saline, or normal saline.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
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, Buddihisst Tzu Chi General Hospital and Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247557
- Sponsor's protocol ID
- TCGHUROL011
- Status last verified
- Mar 2017
- First submitted
- 15 Sep 2014
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD cannot be released unless researchers obtain the approval from the Ethics Committee of the Buddhist Tzu Chi General Hospital, Hualien, Taiwan
Publications
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PubMed 32734597
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis - a Randomized, Double-blind, Placebo-controlled, Prospective Study
- ClinicalTrials.gov ID
- NCT02247557
- Acronym / sponsor ID
- TCGHUROL011
- Conditions
- Interstitial Cystitis
- Keywords
- IC/PBS, VAS, Botulinum Toxin A, Lipotoxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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.
To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS
Detailed description
Liposome has been proven able to carry botulinum toxin protein across the cell membrane and effect on urothelial receptors in human overactive bladder. However, the therapeutic duration is limited to 1 month. Intravesical BOTOX injection in patients with interstitial cystitis (IC) can effectively decrease pain, improve bladder capacity and decrease frequency. However, the need of cystoscopic injection limits its wide application.
A total of 100 eligible women with non-ulcer IC will be enrolled to receive intravesical instillation of Lipotoxin containing 80mg liposomes and 200U BOTOX (treatment group), 200U BOTOX in normal saline (N/S) (active control group) or normal saline (placebo control group) single treatment. At least 90 evaluable patients will be included for the final analysis.
All patients should have IC symptoms for at least 6 months, and proven to have grade 2 diffused glomerulations after cystoscopic hydrodistention (HD) within recent 1 year without Hunner's lesion. Patients should not have UTI in recent 12 months, no urinary tract stone. Patients should have been proven free of detrusor overactivity or bladder outlet obstruction. Patients should not receive intravesical hyaluronic acid treatment in recent 6 months, or intravesical Botox injection in recent 12 months. Intravesical instillation of Lipotoxin at OPD and the patient should hold the solution for 2 hours to allow bladder distention. Retreatment with Lipotoxin at 3 months if patient reports ineffective.
Primary end-point is the change of the O'Leary-Sant symptom score (including ICSI and ICPI) from baseline to 1 month after treatment. Secondary endpoints include VAS, daily frequency, nocturia and FBC as record in 3-day voiding diary, Qmax, voided volume, PVR and global response assessment (GRA). Four visits are required at baseline screening (before first treatment), treatment (V1), 2 weeks (V2), 4 weeks (V3, primary end-point) and 12 weeks (V4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- This is a double-blind, randomized, placebo-controlled physician initiated study enrolled patients with refractory IC/BPS. Patients were assigned to intravesical instillation of lipotoxin (onabotulinumtoxinA 200 U with 80mg sphingomyelin), onabotulinumtoxinA 200 U in normal saline, or normal saline.
| Arm | Type | Receives |
|---|---|---|
| Group A: Liposome encapsulated BoNT-A | Experimental | Drug: Liposome encapsulated BoNT-ALiposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation |
| Group B: BoNT-A 200 U in Normal saline | Experimental | Drug: BOTOX 200U in normal salineBOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation |
| Group C: Normal saline | Placebo comparator | Drug: Normal salineNormal saline (N/S) 50ml in single intravesical instillation |
Who may qualify
- Ages
- 20 to 80 years
- 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 enrollment
Key exclusion criteria (12 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 |
|---|---|---|
| Liposome encapsulated BoNT-AAlso: Liposome, onabotulinumtoxinA 200ULiposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation | Drug | Group A: Liposome encapsulated BoNT-A |
| BOTOX 200U in normal salineAlso: onabotulinumtoxinA 200UBOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation | Drug | Group B: BoNT-A 200 U in Normal saline |
| Normal salineAlso: SalineNormal saline (N/S) 50ml in single intravesical instillation | Drug | Group C: Normal saline |
Primary outcome
Change of the O'Leary-Sant symptom score
Time frame: Baseline and 1 month
Change of the O'Leary-Sant symptom score from baseline to 1 month after the treatment day
10 secondary outcomes
Net changes of the Visual Analog Scale (VAS)
Time frame: Baseline and 1 month
Net changes of the functional bladder capacity (FBC)
Time frame: Baseline and 1 month
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary
Time frame: Baseline and 1 month
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary
Time frame: Baseline and 1 month
Net Change of the Global response assessment (GRA)
Time frame: Baseline and 1 month
Net Change of the maximum flow rate
Time frame: Baseline and 1 month
Net Change of the voided volume
Time frame: Baseline and 1 month
Net Change of the PVR
Time frame: Baseline and 1 month
Net Change of the urinary nerve growth factor
Time frame: Baseline and 1 month
Net Change of the cytokines level
Time frame: Baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 32734597Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
- Individual participant dataSharing planned: No. IPD cannot be released unless researchers obtain the approval from the Ethics Committee of the Buddhist Tzu Chi General Hospital, Hualien, Taiwan
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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, Buddihisst Tzu Chi General Hospital and Tzu Chi University
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 Liposome encapsulated BoNT-A, BOTOX 200U 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 12 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: finished, as of the sponsor's last update on 9 Mar 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the O'Leary-Sant symptom score (time frame: Baseline and 1 month). 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 NCT02247557, 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 9 Mar 2017.