Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Artann Laboratories2 sites in 1 country138 target enrollmentAugust 2014

ConditionsPelvic Organ Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Artann Laboratories
Enrollment: 138
Locations: 2
Primary Endpoint: Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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/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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

January 2016

Last Updated

7 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Artann Laboratories

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 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.