NCT03477214

Tactile Imaging and Electromyography

Tactile Imaging and Electromyography of Female Pelvic Floor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Advanced Tactile Imaging, Inc. · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: —

Summary

Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate of 27.2% among man and 43.1% among women, respectively. Urine Incontinence was reported to affect 15% of women ages 40 to 49, 25% ages 60 to 69, and 38% of women age 80 and older.

Detailed description

Pelvic floor disorders result from neuro-urinary pathology as well as muscle functional impairment due to changes in bio-mechanical properties of soft tissues with the age. That is why pelvic floor characterization and diagnosis must include electomyographic (EMG) and biomechanical measurements (pressure) or better if EMG and tactile imaging with improved spatial resolution. The quantitative and objective imaging data for pelvic floor conditions could allow an effective treatment of OAB and UI. In this research the investigators propose to develop a new device for accurate diagnosis of the diseased conditions by measuring the pelvic floor muscles strength and EMG activity. The value to society is high given by the prevalence of OAB and UI.

Conditions

• Urinary Incontinence
• Overactive Bladder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biomechanical and electromyography mapping	The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina.

Timeline

• Start date: 2017-12-24
• Primary completion: 2020-03-10
• Completion: 2020-03-15
• First posted: 2018-03-26
• Last updated: 2020-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study