Dynamic MRI of the Behaviour of Female Pelvic Floor

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747370
• Other study ID #: KUH5302421
• Status: Completed
• Phase: Phase 0
• First received: September 3, 2008
• Last updated: September 4, 2008
• Start date: January 2002
• Est. completion date: June 2008

Study information

• Verified date: September 2008
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Genital Prolapse
• Prolapse
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• movement of midurethra, bladder neck, cervix and rectum

Locations

Country	Name	City	State
Finland	Department of Gynecology and Radiology, Kuopio University Hospital	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI		5 years	No