Status:
COMPLETED
Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02247557
Start Date
September 1 2014
End Date
February 1 2017
Last Update
March 9 2017
Active Locations (1)
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1
Buddhist Tzu Chi General Hospital
Hualien City, Taiwan, 970