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OpenTrials
Completed

NCT Number: NCT02925585

Vaginal Tactile Imaging for Pelvic Floor Prolapse

The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Pelvic Floor Institute, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Pre/post imaging

Other

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2016
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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