Vaginal Tactile Imaging for Pelvic Floor Prolapse

NCT02925585 | Completed

• 2 other identifiers: VTI09SB1AG034714
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 5

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm

  Tissue elasticity is measured for entire anterior and posterior compartments

  pre-surgery and post-surgery (4-6 months after surgery) measurements

• Pelvic floor muscle strength change after the surgery measured as a pressure dynamic feedback during muscle contractions. Unit of measure: mmHg

  Muscle strength is measured during voluntary and involuntary muscle contractions, involuntary relaxation and Valsalva maneuver.

  pre-surgery and post-surgery (4-6 months after surgery) measurements

Study Arms (1)

Pre/post pelvic floor surgery imaging

Other: Pre/post imaging

Interventions

Pre/post imaging OTHER

Pre/post pelvic floor surgery imaging

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for pelvic floor surgery

You may qualify if:

• Subject is female of 21 years or older, and
• No prior pelvic floor surgery, and
• 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

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.

Sponsors & Collaborators

• Artann Laboratories: lead
• National Institute on Aging (NIA): collaborator

Study Sites (5)

The Pelvic Floor Institute

Tampa, Florida, 33606, United States

Location

Princeton Urogynecology PU

Princeton, New Jersey, 08540, United States

Location

The Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Inova Health System Foundation

Falls Church, Virginia, 22042, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23501, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 6, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

US (5)