Dynamic MRI of the Behaviour of Female Pelvic Floor

September 4, 2008 updated by: Kuopio University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

74

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • Department of Gynecology and Radiology, Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

University of Eastern Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (Estimate)

September 5, 2008

Study Record Updates

Last Update Posted (Estimate)

September 5, 2008

Last Update Submitted That Met QC Criteria

September 4, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5302421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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