Tactile Imaging and Electromyography

Completed

• Conditions: Overactive Bladder; Urinary Incontinence
• Interventions: Diagnostic Test: Biomechanical and electromyography mapping

• Registration Number: NCT03477214
• Lead Sponsor: Advanced Tactile Imaging, Inc.

Brief 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.

Study Timeline

• Study Start: 2017-12-24
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Women above age of 21 with normal pelvic floor condition for the control
• Women with SUI conditions as defined by International Continence Society guidelines
• Women with OAB conditions as defined by American Urological Association and Society of Urodinamics, Female Pelvic Medicine & Urogenital Reconstruction.

Exclusion Criteria

• Any prior pelvic floor surgery related to SUI, POP or OAB conditions
• Active skin infection or ulceration within the vagina
• Presence of the vaginal septum
• Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
• Ongoing radiation therapy for pelvic cancer; impacted stool
• Surgically absent rectum or bladder
• Sever hemorrhoids
• Significant circulatory or cardiac conditions that could cause excessive risk
• Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urinary incontinence	Biomechanical and electromyography mapping	Urinary incontinence conditions. Transvaginal biomechanical and electromyography mapping will be completed.
Overactive bladder	Biomechanical and electromyography mapping	Overactive bladder conditions
Normal	Biomechanical and electromyography mapping	No UI, no OAB conditions. Transvaginal biomechanical and electromyography mapping will be completed.

Primary Outcome Measures

Name	Time	Method
Transvaginal biomechanical maps	Four months	Transvaginal biomechanical maps (pressures in Pa) will be recorded and compared for UI and OAB versus normal conditions.
Transvaginal electromyography maps	Four months	Transvaginal electromyography maps (electrical voltages in mV) will be recorded and compared for UI and OAB versus normal conditions.

Trial Locations

Locations (2)

Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM); 🇺🇸 Allentown, Pennsylvania, United States

Princeton Urogynecology; 🇺🇸 Princeton, New Jersey, United States