Tactile Imaging and Electromyography

Tactile Imaging and Electromyography of Female Pelvic Floor

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Urinary Incontinence
• Intervention / Treatment: Diagnostic test: Biomechanical and electromyography mapping

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Urogynecology
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

There is no inclusion or exclusion criteria based on ethnic background, religion, or other division of population other than these stated in Exclusion Criteria section.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal; No UI, no OAB conditions. Transvaginal biomechanical and electromyography mapping will be completed.	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.
Urinary incontinence; Urinary incontinence conditions. Transvaginal biomechanical and electromyography mapping will be completed.	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.
Overactive bladder; Overactive bladder conditions	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Advanced Tactile Imaging, Inc.
• Collaborators: Princeton Urogynecology
• Investigators: Study Director: Heather van Raalte, MD, Princeton Urogynecology

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2017
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Incontinence
• Other Study ID Numbers: TIEMG08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No