Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

June 6, 2018 updated by: Artann Laboratories
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Princeton Urogynecology
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Institute of Female Pelvic Medicine and Reconstructive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population comprises of patients referred to a gynecologist/urogynecologist for either regular examination or with a pelvic floor organ concern.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pre/post surgery pelvic floor assessment
Conservative treatmen monitoring
Pelvic floor muscle contrictions
Imaging reproducibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm
Time Frame: From 1 day to 12 months
From 1 day to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artann Laboratories

Collaborators

National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

June 7, 2018

Last Update Submitted That Met QC Criteria

June 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTI05
  • R44AG034714 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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