Vaginal Tactile Imaging for Pelvic Floor Prolapse

Sponsor
Artann Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT02925585
Collaborator
National Institute on Aging (NIA) (NIH)
119
5
27
23.8
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pre/post imaging

Study Design

Study Type:
Observational
Actual Enrollment :
119 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Pre/post pelvic floor surgery imaging

Other: Pre/post imaging

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Pelvic Floor Institute Tampa Florida United States 33606
2 Princeton Urogynecology PU Princeton New Jersey United States 08540
3 The Institute for Female Pelvic Medicine and Reconstructive Surgery Allentown Pennsylvania United States 18103
4 Inova Health System Foundation Falls Church Virginia United States 22042
5 Eastern Virginia Medical School Norfolk Virginia United States 23501

Sponsors and Collaborators

  • Artann Laboratories
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT02925585
Other Study ID Numbers:
  • VTI09
  • SB1AG034714
First Posted:
Oct 6, 2016
Last Update Posted:
Mar 21, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2019