Dynamic MRI of the Behaviour of Female Pelvic Floor

Sponsor

Kuopio University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00747370

Collaborator

University of Eastern Finland (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Genital Prolapse	Procedure: movement of midurethra, bladder neck, cervix and rectum	Early Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

The Suitability of Dynamic MRI for Pelvic Floor, Bladder Neck and Midurethra

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 16 healthy volunteers with no complaints of urinary symptoms and without urogenital prolapse of more than first degree.	Procedure: movement of midurethra, bladder neck, cervix and rectum
Other: 2 Forty two stress urinary incontinence patients without prior urogenital prolapse or incontinence operation and without genital prolapse more than first degree	Procedure: movement of midurethra, bladder neck, cervix and rectum
Other: 3 16 genital prolapse women without prior prolapse operations or any symptoms of incontinence	Procedure: movement of midurethra, bladder neck, cervix and rectum

Arm

Intervention/Treatment

Other: 1

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

Procedure: movement of midurethra, bladder neck, cervix and rectum

Other: 2

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

Procedure: movement of midurethra, bladder neck, cervix and rectum

Other: 3

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

Procedure: movement of midurethra, bladder neck, cervix and rectum

Outcome Measures

Primary Outcome Measures

The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gynecology and Radiology, Kuopio University Hospital	Kuopio		Finland	70211

Sponsors and Collaborators

Kuopio University Hospital
University of Eastern Finland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00747370

Other Study ID Numbers:

KUH5302421

First Posted:

Sep 5, 2008

Last Update Posted:

Sep 5, 2008

Last Verified:

Sep 1, 2008

Keywords provided by , ,

stress urinary incontinence

Tension free vaginal tape

tension free vaginal tape obturator

genital prolapse

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Prolapse

Study Results

No Results Posted as of Sep 5, 2008