Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vaginal Tactile Imaging for Pelvic Floor Prolapse

NCT02925585

Pelvic Organ Prolapse

COMPLETED

Validation of Transvaginal Tactile Imaging

NCT01491334

Pelvic Organ Prolapse

COMPLETED

Development Study Using Vaginal Tactile Imager

NCT01111916

Pelvic Organ Prolapse

COMPLETED

Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery

NCT03883867

Pelvic Floor Perineal Rupture Obstetric Trauma

COMPLETED

Tactile Imaging and Electromyography

NCT03477214

Urinary Incontinence Overactive Bladder

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Organ Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre/post surgery pelvic floor assessment

No interventions assigned to this group

Conservative treatmen monitoring

No interventions assigned to this group

Pelvic floor muscle contrictions

No interventions assigned to this group

Imaging reproducibility

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes