Vaginal Tactile Imaging for Pelvic Floor Prolapse
Study Details
Study Description
Brief Summary
The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Pre/post pelvic floor surgery imaging
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Other: Pre/post imaging
|
Outcome Measures
Primary Outcome Measures
- Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm [pre-surgery and post-surgery (4-6 months after surgery) measurements]
Tissue elasticity is measured for entire anterior and posterior compartments
- Pelvic floor muscle strength change after the surgery measured as a pressure dynamic feedback during muscle contractions. Unit of measure: mmHg [pre-surgery and post-surgery (4-6 months after surgery) measurements]
Muscle strength is measured during voluntary and involuntary muscle contractions, involuntary relaxation and Valsalva maneuver.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is female of 21 years or older, and
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No prior pelvic floor surgery, and
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One of the following:
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:
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Active skin infection or ulceration within the vagina
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Presence of a vaginal septum;
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Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
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Ongoing radiation therapy for pelvic cancer;
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Impacted stool;
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Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
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Severe hemorrhoids;
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Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
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Current pregnancy.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The Pelvic Floor Institute | Tampa | Florida | United States | 33606 |
2 | Princeton Urogynecology PU | Princeton | New Jersey | United States | 08540 |
3 | The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | United States | 18103 |
4 | Inova Health System Foundation | Falls Church | Virginia | United States | 22042 |
5 | Eastern Virginia Medical School | Norfolk | Virginia | United States | 23501 |
Sponsors and Collaborators
- Artann Laboratories
- National Institute on Aging (NIA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VTI09
- SB1AG034714