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Completed

NCT Number: NCT00747370

Dynamic MRI of the Behaviour of Female Pelvic Floor

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Prolapse Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Gynecology and Radiology, Kuopio University Hospital

Kuopio, 70211, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

movement of midurethra, bladder neck, cervix and rectum

Procedure

Primary outcomes

  1. The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Eastern Finland

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2008
First posted
Sep 5, 2008
Registry last updated
Sep 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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