Clinical trial NCT03477214: Tactile Imaging and Electromyography
Official title: Tactile Imaging and Electromyography of Female Pelvic Floor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Overactive Bladder
Lead sponsor: Advanced Tactile Imaging, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Princeton Urogynecology
First posted: 2018-03-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Transvaginal biomechanical maps
timeFrame: Four months
measure: Transvaginal electromyography maps
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Princeton Urogynecology
state: New Jersey
city: Allentown
country: United States
facility: Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM)
state: Pennsylvania
Study officials:
affiliation: Princeton Urogynecology
name: Heather van Raalte, MD
role: STUDY_DIRECTOR
References: