Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Pelvic Organ Prolapse Clinical Trial

Official title:

Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294383
• Other study ID #: VTI05
• Secondary ID: R44AG034714
• Status: Completed
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: June 2018
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	Institute of Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	Princeton Urogynecology	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Artann Laboratories	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm		From 1 day to 12 months