Dynamic MRI of the Behaviour of Female Pelvic Floor

This study has been completed.

Sponsor:

Collaborator:

University of Eastern Finland

Information provided by:

Kuopio University Hospital

ClinicalTrials.gov Identifier:

NCT00747370

First received: September 3, 2008

Last updated: September 4, 2008

Last verified: September 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	September 3, 2008
Last Updated Date	September 4, 2008
Start Date ^ICMJE	January 2002
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 4, 2008)	The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00747370 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dynamic MRI of the Behaviour of Female Pelvic Floor
Official Title ^ICMJE	The Suitability of Dynamic MRI for Pelvic Floor, Bladder Neck and Midurethra
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.
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 Type ^ICMJE	Interventional
Study Phase	Phase 0
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Stress Urinary Incontinence Genital Prolapse
Intervention ^ICMJE	Procedure: movement of midurethra, bladder neck, cervix and rectum
Study Arm (s)	1 16 healthy volunteers with no complaints of urinary symptoms and without urogenital prolapse of more than first degree. Intervention: Procedure: movement of midurethra, bladder neck, cervix and rectum 2 Forty two stress urinary incontinence patients without prior urogenital prolapse or incontinence operation and without genital prolapse more than first degree Intervention: Procedure: movement of midurethra, bladder neck, cervix and rectum 3 16 genital prolapse women without prior prolapse operations or any symptoms of incontinence Intervention: Procedure: movement of midurethra, bladder neck, cervix and rectum
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	74
Completion Date	June 2008
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT00747370
Other Study ID Numbers ^ICMJE	KUH5302421
Has Data Monitoring Committee	No
Responsible Party	Kirsi Rinne, Kuopio University Hospital
Study Sponsor ^ICMJE	Kuopio University Hospital
Collaborators ^ICMJE	University of Eastern Finland
Investigators ^ICMJE	Not Provided
Information Provided By	Kuopio University Hospital
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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