NCT00747370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2002

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
Last Updated

September 5, 2008

Status Verified

September 1, 2008

Enrollment Period

5.9 years

First QC Date

September 3, 2008

Last Update Submit

September 4, 2008

Conditions

Stress Urinary IncontinenceGenital Prolapse

Keywords

stress urinary incontinenceTension free vaginal tapetension free vaginal tape obturatorgenital prolapse

Outcome Measures

Primary Outcomes (1)

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

    5 years

Study Arms (3)

1

OTHER

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

OTHER

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

OTHER

16 genital prolapse women without prior prolapse operations or any symptoms of incontinence

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

Interventions

movement of midurethra, bladder neck, cervix and rectumPROCEDURE
123

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy women without any urogenital symptoms
  • stress urinary incontinence ( group II )
  • genital prolapse of third degree ( group III)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology and Radiology, Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 5, 2008

Study Start

January 1, 2002

Primary Completion

December 1, 2007

Study Completion

June 1, 2008

Last Updated

September 5, 2008

Record last verified: 2008-09

Locations

FI(1)