Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Artann Laboratories
- Enrollment
- 119
- Locations
- 5
- Primary Endpoint
- Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is female of 21 years or older, and
- •No prior pelvic floor surgery, and
- •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
- •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.
Outcomes
Primary Outcomes
Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm
Time Frame: 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
Time Frame: 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.