Dynamic MRI of the Behaviour of Female Pelvic Floor

NCT ID: NCT00747370

Last Updated: 2008-09-05

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

Clinical Phase

EARLY_PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study was to test the suitability of dynamic magnetic resonance imaging for the pelvic floor floor, bladder neck and urethra in healthy volunteers, in stress incontinent patient and in women with genital prolapse.

Detailed Description

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Traditional methods for evaluation of urinary incontinence in women include urodynamics, cystourethroscopy, cystourethrography and ultrasonography.Magnetic resonance imaging (MRI) offers a new tool for evaluation of morphology and function of the urogenital compartment of the female pelvis. Moreover, MRI gives opportunity to study function of the pelvic floor organs in terms of mobility and reactions during different physiological and provocative activities.

The aim of the present study was by means of dynamic MRI to evaluate the behaviour of the mid-urethra, bladder neck, cervix and rectum in different maneuvers in three different study groups. Sixteen healthy volunteers with no complaints of urinary symptoms or urogenital prolapses, 42 stress urinary incontinence patients and 16 women with third degree genital prolapse were examined respectively.

Conditions

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Stress Urinary Incontinence Genital Prolapse

Keywords

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stress urinary incontinence Tension free vaginal tape tension free vaginal tape obturator genital prolapse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

16 healthy volunteers with no complaints of urinary symptoms and without urogenital prolapse of more than first degree.

Group Type OTHER

movement of midurethra, bladder neck, cervix and rectum

Intervention Type PROCEDURE

2

Forty two stress urinary incontinence patients without prior urogenital prolapse or incontinence operation and without genital prolapse more than first degree

Group Type OTHER

movement of midurethra, bladder neck, cervix and rectum

Intervention Type PROCEDURE

3

16 genital prolapse women without prior prolapse operations or any symptoms of incontinence

Group Type OTHER

movement of midurethra, bladder neck, cervix and rectum

Intervention Type PROCEDURE

Interventions

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movement of midurethra, bladder neck, cervix and rectum

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* healthy women without any urogenital symptoms
* stress urinary incontinence ( group II )
* genital prolapse of third degree ( group III)

Exclusion Criteria

* previous incontinence or prolapse surgery
* lower urinary tract anomaly
* current UTI or \> 3 UTI episodes within the past year
* previous radiation therapy of the pelvis
* active malignancy
* neurogenic disease which can be associated with bladder disorders
* patient unable to understand the purpose of the study
* patient immobile
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kuopio University Hospital

Locations

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Department of Gynecology and Radiology, Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5302421

Identifier Type: -

Identifier Source: org_study_id