NCT02954042

Pelvital Stress Urinary Incontinence Training Device: P-SUIT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Pelvital USA, Inc. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigation is to compare the clinical benefits of using the Pelvital product, in comparison to a sham procedure as a noninvasive treatment for female incontinence

Detailed description

120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects will conduct their respective therapy five minutes a day over the course of six weeks. At weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all patients in the control arm will have the option to cross over into the treatment arm if no improvement in symptoms has been shown.

Conditions

• Incontinence

Interventions

Type	Name	Description
DEVICE	Pelvital probe	Pelvital probe
DEVICE	Placebo Probe	Placebo Probe

Timeline

• Start date: 2017-03-10
• Primary completion: 2019-10-30
• Completion: 2019-10-30
• First posted: 2016-11-03
• Last updated: 2021-04-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study