NCT05611970

Pippa Pessary Study (Clinical Trial)

Pippa Fitness Pessary Device Effectiveness and Safety Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Liv Labs Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, interventional, single arm, multi-clinic study where each adult female participant with stress urinary incontinence (SUI) serves as her own control (vaginal pessary use vs. no vaginal pessary).

Detailed description

The overall objectives of this clinical study are to demonstrate the effectiveness and safety of the Pippa Fitness Pessary (device) when self-administered and used in a home environment. Specifically, this study will evaluate the effectiveness of the Pippa Fitness Pessary by assessing reduction in urine leakage in up to 90 women with Stress Urinary Incontinence. Effectiveness will be assessed by percentage reduction in 1-hour pad weight gain, reduction of stress urinary incontinence episodes per day, and a quality-of-life questionnaire. The safety of the Pippa Fitness Pessary will be evaluated by assessing all adverse events, including the results of urinalysis and vaginal examination.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Vaginal pessary	A reusable vaginal pessary for stress urinary incontinence

Timeline

• Start date: 2023-02-13
• Primary completion: 2024-04-09
• Completion: 2024-04-09
• First posted: 2022-11-10
• Last updated: 2026-03-13
• Results posted: 2026-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study