Vaginal Tactile Imaging for Pelvic Floor Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925585
• Other study ID #: VTI09
• Secondary ID: SB1AG034714
• Status: Completed
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Pre/post imaging

Locations

Country	Name	City	State
United States	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	Princeton Urogynecology PU	Princeton	New Jersey
United States	The Pelvic Floor Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Artann Laboratories	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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