Skip to main content
OpenTrials
Completed

NCT Number: NCT02294383

Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Princeton Urogynecology, Princeton, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • No prior pelvic floor surgery, and
  • 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

Primary outcomes

  1. Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm

    Time frame: From 1 day to 12 months

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 19, 2014
Registry last updated
Jun 7, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.