Status:
COMPLETED
Tactile Imaging and Electromyography
Lead Sponsor:
Advanced Tactile Imaging, Inc.
Collaborating Sponsors:
Princeton Urogynecology
Conditions:
Urinary Incontinence
Overactive Bladder
Eligibility:
FEMALE
21+ years
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 ...
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 24 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03477214
Start Date
December 24 2017
End Date
March 15 2020
Last Update
April 13 2020
Active Locations (2)
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1
Princeton Urogynecology
Princeton, New Jersey, United States, 08540
2
Institute of Female Pelvic Medicine & Reconstructive Surgery (IFPM)
Allentown, Pennsylvania, United States, 18103