Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:21 - Any
Updated:6/9/2018
Start Date:August 2014
End Date:January 2016

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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.
We found this trial at
2
sites
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania 18105
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Allentown, PA
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Princeton Urogynecology
Princeton, New Jersey 08540
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Princeton, NJ
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