Interstitial Cystitis Clinical Trial
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
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).
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