NCT02179099

Safety and Efficacy of Intravesical Botulinum Toxin in TC-3 Gel in OAB Patients

Pilot Study Evaluating Safety and Efficacy of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in OAB Patients

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: UroGen Pharma Ltd. · Industry
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm pilot study evaluating the feasibility and preliminary safety of a single intravesical instillation of TC-3 gel mixed with botulinum toxin (BTX) for symptomatic improvement in overactive bladder patients.

Detailed description

BTX is considered as therapeutic option for overactive bladder (OAB). Randomized placebo-controlled studies have shown that BTX administered by intramural injection into the bladder wall in patients with OAB leads to significant improvement in urodynamic parameters and quality of life. (Schurch 2008). On the other hand, the animal study suggests that intravesically applied BTX acts to decrease frequency of bladder contraction by inhibiting sensory mechanism in the urothelium rather than directly through inhibition of the smooth muscle contraction. (Khera 2005). The efficacy of intravesical BTX instillation was only tested in a few open label trials for overactive bladder patients whereby the clinical improvement observed was short-lasting with a mean duration of 6.8 weeks (Petrou 2009, Krhut 2011). The short exposure duration of the urothelium to BTX could be one of the factors responsible for the lack of a sustained effect. TC-3 is a hydrogel with reverse thermal gelation properties that when mixed with BTX and instilled intravesically serves as the drug reservoir allowing for gradual release of BTX and thereby for its extended contact with bladder urothelium.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	BTX mixed with TC-3 Gel	Patients will be treated with a single intravesical instillation of 40 ml TC-3 gel mixed with 300U BTX

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-11-01
• Completion: 2016-02-01
• First posted: 2014-07-01
• Last updated: 2016-03-01

Locations

1 site across 1 country: Israel