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Dynamic MRI of the Behaviour of Female Pelvic Floor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00747370
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : September 5, 2008
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by:
Kuopio University Hospital

Tracking Information
First Submitted Date  ICMJE September 3, 2008
First Posted Date  ICMJE September 5, 2008
Last Update Posted Date September 5, 2008
Study Start Date  ICMJE January 2002
Actual 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Stress Urinary Incontinence
  • Genital Prolapse
Intervention  ICMJE Procedure: movement of midurethra, bladder neck, cervix and rectum
Study Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: September 4, 2008)
74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747370
Other Study ID Numbers  ICMJE KUH5302421
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirsi Rinne, Kuopio University Hospital
Study Sponsor  ICMJE Kuopio University Hospital
Collaborators  ICMJE University of Eastern Finland
Investigators  ICMJE Not Provided
PRS Account 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