NCT Number: NCT02925585
Vaginal Tactile Imaging for Pelvic Floor Prolapse
The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.
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Notify MeKey information
Conditions
Age range
21 year and older
Sex eligibility
Female
Study type
Observational
Primary location
The Pelvic Floor Institute, Tampa, Florida, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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.
Sponsors and collaborators
Lead sponsor
Artann Laboratories
Industry
Collaborators
- National Institute on Aging (NIA)
Registry information
Official study title
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Oct 6, 2016
- Registry last updated
- Mar 21, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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