NCT01608789

Virtue® European Study

Virtue® Male Sling European Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.

Detailed description

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted at up to thirteen centers in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling. One hundred and twenty-one subjects, satisfying criteria for selection, will be implanted with no more than 15 implanted per site. The study's primary end point will be evaluated at 12 months with continued data collection through 36 months.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Virtue® Male Sling	The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD).

Timeline

• Start date: 2012-08-27
• Primary completion: 2016-06-28
• Completion: 2018-06-11
• First posted: 2012-05-31
• Last updated: 2020-06-11

Locations

14 sites across 8 countries: Belgium, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom