Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

NCT02294383 | Completed

• 2 other identifiers: VTI05R44AG034714
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Floor Biomechanics; Tissue Elasticity; Tactile Imaging

Outcome Measures

Primary Outcomes (1)

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

  From 1 day to 12 months

Study Arms (4)

Pre/post surgery pelvic floor assessment

Conservative treatmen monitoring

Pelvic floor muscle contrictions

Imaging reproducibility

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Artann Laboratories: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Institute of Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (3)

• Egorov V, van Raalte H, Sarvazyan AP. Vaginal tactile imaging. IEEE Trans Biomed Eng. 2010 Jul;57(7):1736-44. doi: 10.1109/TBME.2010.2045757. Epub 2010 May 17.

  PMID: 20483695 BACKGROUND

• Egorov V, van Raalte H, Lucente V. Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging. Int Urogynecol J. 2012 Apr;23(4):459-66. doi: 10.1007/s00192-011-1592-z. Epub 2011 Nov 10.

  PMID: 22072417 BACKGROUND

• van Raalte H, Egorov V. Characterizing female pelvic floor conditions by tactile imaging. Int Urogynecol J. 2015 Apr;26(4):607-9. doi: 10.1007/s00192-014-2549-9. Epub 2014 Oct 25.

  PMID: 25344223 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 7, 2018

Record last verified: 2018-06

Locations

US (2)