NCT01676662

Solace European Confirmatory Trial

An Evaluation of the Solace Bladder Control System in the Treatment of Female Subjects With Stress Urinary Incontinence

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

Summary

The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

Detailed description

Subject will undergo treatment with the Solace Bladder Control System or a sham procedure, with the results being compared at 3 months. All patients undergoing sham treatment are treated at 3 months.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Solace Bladder Control System	Subjects may undergo treatment every 12 months until study completion.
DEVICE	Solace Sham Treatment	Sham procedure that resembles treatment with the Solace Bladder Control System

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-06-01
• Completion: 2017-01-01
• First posted: 2012-08-31
• Last updated: 2017-06-23

Locations

7 sites across 3 countries: Belgium, Italy, Netherlands