Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02294383

Enrollment

138

Registered

2014-11-19

Start date

2014-08-31

Completion date

2016-01-31

Last updated

2018-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Floor Biomechanics, Tissue Elasticity, Tactile Imaging

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm	From 1 day to 12 months

Countries

United States

Outcome results