Vaginal Tactile Imaging for Pelvic Floor Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre/post pelvic floor surgery imaging

Pre/post imaging

Intervention Type OTHER

Interventions

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Pre/post imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subject is female of 21 years or older, and
2. No prior pelvic floor surgery, and
3. One of the following:

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

1. Active skin infection or ulceration within the vagina
2. Presence of a vaginal septum;
3. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
4. Ongoing radiation therapy for pelvic cancer;
5. Impacted stool;
6. Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
7. Severe hemorrhoids;
8. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
9. Current pregnancy.

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No