Dynamic MRI of the Behaviour of Female Pelvic Floor

Early Phase 1

Completed

• Conditions: Stress Urinary Incontinence; Genital Prolapse
• Interventions: Procedure: movement of midurethra, bladder neck, cervix and rectum

• Registration Number: NCT00747370
• Lead Sponsor: Kuopio University Hospital

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 Timeline

• Study Start: 2002-01
• Primary Completion: 2007-12
• Study Completion: 2008-06
• Status Verified: 2008-09
• Study First Submitted: 2008-09-03
• Study First Submitted QC: 2008-09-04
• Last Update Submitted: 2008-09-04
• Study First Posted: 2008-09-05
• Last Update Posted: 2008-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	movement of midurethra, bladder neck, cervix and rectum	16 healthy volunteers with no complaints of urinary symptoms and without urogenital prolapse of more than first degree.
2	movement of midurethra, bladder neck, cervix and rectum	Forty two stress urinary incontinence patients without prior urogenital prolapse or incontinence operation and without genital prolapse more than first degree
3	movement of midurethra, bladder neck, cervix and rectum	16 genital prolapse women without prior prolapse operations or any symptoms of incontinence

Primary Outcome Measures

Name	Time	Method
The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI	5 years

Trial Locations

Locations (1)

Department of Gynecology and Radiology, Kuopio University Hospital; 🇫🇮 Kuopio, Finland