Vaginal Tactile Imaging for Pelvic Floor Prolapse

Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02925585

Enrollment

119

Registered

2016-10-06

Start date

2016-09-30

Completion date

2018-12-31

Last updated

2019-03-21

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

Conditions

Pelvic Organ Prolapse

Brief summary

The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.

Interventions

OTHERPre/post imaging

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subject is female of 21 years or older, and 2. No prior pelvic floor surgery, and 3. 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

Exclusion criteria

1. Active skin infection or ulceration within the vagina 2. Presence of a vaginal septum; 3. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder; 4. Ongoing radiation therapy for pelvic cancer; 5. Impacted stool; 6. Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia; 7. Severe hemorrhoids; 8. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician; 9. Current pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm	pre-surgery and post-surgery (4-6 months after surgery) measurements	Tissue elasticity is measured for entire anterior and posterior compartments
Pelvic floor muscle strength change after the surgery measured as a pressure dynamic feedback during muscle contractions. Unit of measure: mmHg	pre-surgery and post-surgery (4-6 months after surgery) measurements	Muscle strength is measured during voluntary and involuntary muscle contractions, involuntary relaxation and Valsalva maneuver.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026