Clinical trial NCT02294383: Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Official title: Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic Floor Biomechanics
Tissue Elasticity
Tactile Imaging
Lead sponsor: Artann Laboratories
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-11-19
Enrollment: 138
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises of patients referred to a gynecologist/urogynecologist for either regular examination or with a pelvic floor organ concern.

Brief summary: The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.


Eligibility criteria: Inclusion Criteria:

* No prior pelvic floor surgery, and
* Normal pelvic floor conditions, or
* POP Stage I affecting one or more vaginal compartment, or
* POP Stage II affecting one or more vaginal compartment, or
* POP Stage III affecting one or more vaginal compartment, or
* POP Stage IV affecting one or more vaginal compartment.

Exclusion Criteria:

* Active skin infection or ulceration within the vagina
* Presence of a vaginal septum;
* Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
* Ongoing radiation therapy for pelvic cancer;
* Impacted stool;
* Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
* Severe hemorrhoids;
* Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
* Current pregnancy.

Primary outcomes:
measure: Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm
timeFrame: From 1 day to 12 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 and Reconstructive Surgery
state: Pennsylvania
Study officials:
References:
citation: Egorov V, van Raalte H, Sarvazyan AP. Vaginal tactile imaging. IEEE Trans Biomed Eng. 2010 Jul;57(7):1736-44. doi: 10.1109/TBME.2010.2045757. Epub 2010 May 17.
citation: Egorov V, van Raalte H, Lucente V. Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging. Int Urogynecol J. 2012 Apr;23(4):459-66. doi: 10.1007/s00192-011-1592-z. Epub 2011 Nov 10.
citation: van Raalte H, Egorov V. Characterizing female pelvic floor conditions by tactile imaging. Int Urogynecol J. 2015 Apr;26(4):607-9. doi: 10.1007/s00192-014-2549-9. Epub 2014 Oct 25.