Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Completed
Conditions studied: Pelvic Organ Prolapse
In brief
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.
Key facts
- Study ID
- NCT02294383
- Run by
- Artann Laboratories
- People needed
- 138
- Starts
- 2014-08-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2018-06-07
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
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
- Princeton Urogynecology — Princeton, New Jersey, United States
- Institute of Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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