Status:
COMPLETED
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Lead Sponsor:
Artann Laboratories
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
21+ years
Brief Summary
The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/managemen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT02294383
Start Date
August 1 2014
End Date
January 1 2016
Last Update
June 7 2018
Active Locations (2)
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1
Princeton Urogynecology
Princeton, New Jersey, United States, 08540
2
Institute of Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103