Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Sponsor

Artann Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT02294383

Collaborator

National Institute on Aging (NIA) (NIH)

138

Enrollment

Locations

Duration (Months)

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse

Study Design

Study Type:

Observational

Actual Enrollment :

138 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Pre/post surgery pelvic floor assessment
Conservative treatmen monitoring
Pelvic floor muscle contrictions
Imaging reproducibility

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princeton Urogynecology	Princeton	New Jersey	United States	08540
2	Institute of Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania	United States	18103