NCT02674269

Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")

A Randomized Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botulinum Toxin (Botox®) Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UroGen Pharma Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.

Detailed description

Overactive bladder (OAB) is a syndrome, defined by the International Continence Society (ICS), as the presence of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of a urinary tract infection (UTI) or other obvious pathology." This study will evaluate a new of mode of treatment, with intravesical bladder instillation with Botox® mixed with TC-3 that may bypass the drawbacks of the current bladder injection treatment mode in OAB patients. Additionally it will provide preliminary safety and efficacy data that may serve as a basis for a larger study exploring safety and efficacy aspects of this new mode of treatment. 50 patients will be randomized in a horse race fashion in a \~2:2:1 ratio. The patients will be screened for up to 3 weeks prior to treatment. The patients will be requested to stop their OAB medications 7 days prior to treatment visit. 20 patients will receive one instillation of 300U of BotuGel (60ml), 20 patients will receive one instillation of 400U of BotuGel (60ml) and 10 patients will receive one instillation of 60 ml RTGel-TC-3 Gel (Placebo), all patients will be followed up for safety and efficacy endpoints until 6 weeks post instillation.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	300 IU of BotuGelTM (60ml)	One intravesical instillation of 300 IU of botox in 60 ml of TC-3 gel
DRUG	400 IU of BotuGelTM (60ml)	One intravesical instillation of 400 IU of botox in 60 ml of TC-3 gel
DEVICE	TC-3 Gel	Intravesical instillation of 60 ml TC-3 gel

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-02-04
• Last updated: 2017-06-16

Locations

2 sites across 1 country: Israel