Tactile Imaging and Electromyography

NCT ID: NCT03477214

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-24
• Study Completion Date: 2020-03-15

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.

Conditions

Urinary Incontinence; Overactive Bladder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Normal

No UI, no OAB conditions. Transvaginal biomechanical and electromyography mapping will be completed.

Biomechanical and electromyography mapping

Intervention Type: DIAGNOSTIC_TEST

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.

Biomechanical and electromyography mapping

Intervention Type: DIAGNOSTIC_TEST

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

Biomechanical and electromyography mapping

Intervention Type: DIAGNOSTIC_TEST

The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Princeton Urogynecology

OTHER

Sponsor Role: collaborator

Advanced Tactile Imaging, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather van Raalte, MD

Role: STUDY_DIRECTOR

Princeton Urogynecology

Locations

Princeton Urogynecology

Princeton, New Jersey, United States

Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM)

Allentown, Pennsylvania, United States

Countries

United States

Other Identifiers

TIEMG08

Identifier Type: -

Identifier Source: org_study_id