Tactile Imaging and Electromyography

Urinary Incontinence Clinical Trial

Official title:

Tactile Imaging and Electromyography of Female Pelvic Floor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477214
• Other study ID #: TIEMG08
• Status: Completed
• Start date: December 24, 2017
• Est. completion date: March 15, 2020

Study information

• Verified date: April 2020
• Source: Advanced Tactile Imaging, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 15, 2020
• Est. primary completion date: March 10, 2020
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
United States	Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM)	Allentown	Pennsylvania
United States	Princeton Urogynecology	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Advanced Tactile Imaging, Inc.	Princeton Urogynecology

Country where clinical trial is conducted

United States, 

Outcome

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