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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
  Purpose

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 Intervention Phase
Stress Urinary Incontinence
Genital Prolapse
 Procedure: movement of midurethra, bladder neck, cervix and rectum
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Suitability of Dynamic MRI for Pelvic Floor, Bladder Neck and Midurethra

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: January 2002
Study Completion Date: June 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
3
16 genital prolapse women without prior prolapse operations or any symptoms of incontinence
 Procedure: movement of midurethra, bladder neck, cervix and rectum

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747370

Locations
Finland
Department of Gynecology and Radiology, Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
  More Information

No publications provided

Responsible Party: Kirsi Rinne, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00747370     History of Changes
Other Study ID Numbers: KUH5302421
Study First Received: September 3, 2008
Last Updated: September 4, 2008
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Kuopio University Hospital:
stress urinary incontinence
Tension free vaginal tape
tension free vaginal tape obturator
genital prolapse

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence
Urinary Incontinence, Stress
Genital Diseases, Female
Pathological Conditions, Anatomical
 Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013