Vaginal Tactile Imaging for Pelvic Floor Prolapse

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: Pre/post imaging

• Registration Number: NCT02925585
• Lead Sponsor: Artann Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-06
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 119

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre/post pelvic floor surgery imaging	Pre/post imaging	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

The Institute for Female Pelvic Medicine and Reconstructive Surgery; 🇺🇸 Allentown, Pennsylvania, United States

Inova Health System Foundation; 🇺🇸 Falls Church, Virginia, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

The Pelvic Floor Institute; 🇺🇸 Tampa, Florida, United States

Princeton Urogynecology PU; 🇺🇸 Princeton, New Jersey, United States