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OpenTrials
Completed

NCT Number: NCT03477214

Tactile Imaging and Electromyography

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Princeton Urogynecology, Princeton, New Jersey, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biomechanical and electromyography mapping

Diagnostic Test

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

Primary outcomes

  1. Transvaginal biomechanical maps

    Time frame: Four months

    Transvaginal biomechanical maps (pressures in Pa) will be recorded and compared for UI and OAB versus normal conditions.

  2. Transvaginal electromyography maps

    Time frame: Four months

    Transvaginal electromyography maps (electrical voltages in mV) will be recorded and compared for UI and OAB versus normal conditions.

Sponsors and collaborators

Lead sponsor

Advanced Tactile Imaging, Inc.

Industry

Collaborators

  • Princeton Urogynecology

Registry information

Official study title

Tactile Imaging and Electromyography of Female Pelvic Floor

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2018
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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