Tactile Imaging and Electromyography

Advanced Tactile Imaging

Status

Completed

Conditions

Urinary Incontinence

Overactive Bladder

Treatments

Diagnostic Test: Biomechanical and electromyography mapping

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03477214

TIEMG08

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.