Tactile Imaging and Electromyography

Completed

Conditions studied: Urinary Incontinence, Overactive Bladder

In brief

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.

Key facts

Study ID: NCT03477214
Run by: Advanced Tactile Imaging, Inc.
People needed: 20
Starts: 2017-12-24
Expected to finish: 2020-03-15
Last updated by the study team: 2020-04-13

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Princeton Urogynecology — Princeton, New Jersey, United States
Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM) — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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