NCT06345677

Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects

An Exploratory, Prospective, Multicenter, Randomized, Double Blind, Placebo + Sham Device Controlled, Study to Assess the Safety, Usability, and Initial Efficacy of the ViXe Combination for Intravesical Administration of XEOMIN® in the Treatment of Female Patients With Idiopathic Overactive Bladder (OAB)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vensica Therapeutics Ltd. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question\[s\] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ViXe Xombination	Combination of Xeomin and the ultrasound based delivery system (Vibe) for intravesical administration of the drug in a minimally invasive procedure
COMBINATION_PRODUCT	Placebo + Sham	Placebo identical in package and appearance to Xeomin together with all steps of Vibe device preparation and activation, but without the actual operation of the ultrasound energy

Timeline

• Start date: 2023-06-09
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2024-04-03
• Last updated: 2024-04-09

Locations

8 sites across 1 country: Portugal