Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT02294383
• Lead Sponsor: Artann Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-19
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

Princeton Urogynecology; 🇺🇸 Princeton, New Jersey, United States

Institute of Female Pelvic Medicine and Reconstructive Surgery; 🇺🇸 Allentown, Pennsylvania, United States