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Vaginal Tactile Imaging for Pelvic Floor Prolapse

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ClinicalTrials.gov Identifier: NCT02925585
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pelvic Organ Prolapse Other: Pre/post imaging

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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 : September 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pre/post pelvic floor surgery imaging Other: Pre/post imaging



Primary Outcome Measures :
  1. Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for pelvic floor surgery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925585


Locations
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United States, Florida
The Pelvic Floor Institute
Tampa, Florida, United States, 33606
United States, New Jersey
Princeton Urogynecology PU
Princeton, New Jersey, United States, 08540
United States, Pennsylvania
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States, 18103
United States, Virginia
Inova Health System Foundation
Falls Church, Virginia, United States, 22042
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23501
Sponsors and Collaborators
Artann Laboratories
National Institute on Aging (NIA)

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Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT02925585     History of Changes
Other Study ID Numbers: VTI09
SB1AG034714 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Scientific Publications of the study results

Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical