NCT03066180

Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

Pilot Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Dr. Bruce B. Allan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, pilot clinical study involving two study groups. This study is designed to demonstrate that the study treatment meets primary efficacy and safety endpoints. The treatment involves radiofrequency treatment to address symptoms of stress urinary incontinence. After receiving the study treatment, subjects will be followed out to 12 months post-treatment. At the Screening Visit, and at each designated follow-up timepoint, subjects will be asked to complete a variety of questionnaires, provide a patient diary, and undergo an objective assessment for urine loss.

Detailed description

This is a prospective, pilot clinical study involving two study groups. Subjects meeting the all the inclusion criteria and none of the exclusion criteria will be enrolled in the study. Subjects will receive a single SUI treatment; subjects in Group 2 will receive two SUI Treatments. At the Screening Visit, and at each pre-designated study follow-up timepoint, subjects will be asked to complete several quality of life questionnaires related to the treated condition. In addition, subjects will provide a bladder voiding diary for review and data collection, and a pad weight test will be conducted and results collected.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Viveve SUI treatment	Non-ablative radiofrequency treatment with surface cooling

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2017-02-28
• Last updated: 2018-12-19

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study