Vaginal Tactile Imaging for Pelvic Floor Prolapse
Completed
Conditions studied: Pelvic Organ Prolapse
In brief
The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.
Key facts
- Study ID
- NCT02925585
- Run by
- Artann Laboratories
- People needed
- 119
- Starts
- 2016-09-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2019-03-21
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Pelvic Floor Institute — Tampa, Florida, United States
- Princeton Urogynecology PU — Princeton, New Jersey, United States
- The Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States
- Inova Health System Foundation — Falls Church, Virginia, United States
- Eastern Virginia Medical School — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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