Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis
1 other identifier
interventional
90
1 country
1
Brief Summary
To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 15, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMarch 9, 2017
March 1, 2017
2.4 years
September 15, 2014
March 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline and 1 month
Secondary Outcomes (10)
Net changes of the Visual Analog Scale (VAS)
Baseline and 1 month
Net changes of the functional bladder capacity (FBC)
Baseline and 1 month
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary
Baseline and 1 month
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary
Baseline and 1 month
Net Change of the Global response assessment (GRA)
Baseline and 1 month
- +5 more secondary outcomes
Study Arms (3)
Group A: Liposome encapsulated BoNT-A
EXPERIMENTALLiposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation
Group B: BoNT-A 200 U in Normal saline
EXPERIMENTALBOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation
Group C: Normal saline
PLACEBO COMPARATORNormal saline (N/S) 50ml in single intravesical instillation
Interventions
Liposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation
BOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation
Normal saline (N/S) 50ml in single intravesical instillation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Buddhist Tzu Chi General Hospital
Hualien City, 970, Taiwan
Related Publications (1)
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.
PMID: 32734597DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hann-Chorng Kuo, M.D.
Department of Urology, Buddihisst Tzu Chi General Hospital and Tzu Chi University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- All participants, investigators and care providers do not know which regimen is given to patients of the three arms.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Urology
Study Record Dates
First Submitted
September 15, 2014
First Posted
September 25, 2014
Study Start
September 1, 2014
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
March 9, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share
IPD cannot be released unless researchers obtain the approval from the Ethics Committee of the Buddhist Tzu Chi General Hospital, Hualien, Taiwan