Stress Urinary IncontinenceEarly Phase 1NCT00747370
Dynamic MRI of the Behaviour of Female Pelvic Floor
A Early Phase 1 study testing movement of midurethra, bladder neck, cervix and rectum in people with Stress Urinary Incontinence and Genital Prolapse, run by Kuopio University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence, Genital Prolapse
- What is being tested?
- movement of midurethra, bladder neck, cervix and rectum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2002to Jun 2008
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy women without any urogenital symptoms
- stress urinary incontinence ( group II )
- genital prolapse of third degree ( group III)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Gynecology and Radiology, Kuopio University Hospital
Kuopio, 70211
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence, Genital Prolapse
- Being tested
- movement of midurethra, bladder neck, cervix and rectum
- Keywords
- stress urinary incontinence, Tension free vaginal tape, tension free vaginal tape obturator, genital prolapse
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
movement of midurethra, bladder neck, cervix and rectumProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 16 healthy volunteers with no complaints of urinary symptoms and without urogenital prolapse of more than first degree. Receives: 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 Receives: Procedure: movement of midurethra, bladder neck, cervix and rectum |
| 3 | Other | 16 genital prolapse women without prior prolapse operations or any symptoms of incontinence Receives: Procedure: movement of midurethra, bladder neck, cervix and rectum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startJan 2002
- Primary completionDec 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747370
- Sponsor's protocol ID
- KUH5302421
- Status last verified
- Sep 2008
- First submitted
- 3 Sep 2008
- Last updated
- 5 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Suitability of Dynamic MRI for Pelvic Floor, Bladder Neck and Midurethra
- ClinicalTrials.gov ID
- NCT00747370
- Acronym / sponsor ID
- KUH5302421
- Conditions
- Stress Urinary Incontinence, Genital Prolapse
- Keywords
- stress urinary incontinence, Tension free vaginal tape, tension free vaginal tape obturator, genital prolapse
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Jan 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: movement of midurethra, bladder neck, cervix and rectum16 healthy volunteers with no complaints of urinary symptoms and without urogenital prolapse of more than first degree. |
| 2 | Other | Procedure: movement of midurethra, bladder neck, cervix and rectumForty two stress urinary incontinence patients without prior urogenital prolapse or incontinence operation and without genital prolapse more than first degree |
| 3 | Other | Procedure: movement of midurethra, bladder neck, cervix and rectum16 genital prolapse women without prior prolapse operations or any symptoms of incontinence |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- healthy women without any urogenital symptoms
- stress urinary incontinence ( group II )
- genital prolapse of third degree ( group III)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| movement of midurethra, bladder neck, cervix and rectum | Procedure or surgery | 1, 2, 3 |
Primary outcome
The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing movement of midurethra, bladder neck, cervix and rectum in people with Stress Urinary Incontinence and Genital Prolapse, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The movement of midurethra, bladder neck, cervix and rectum measured by dynamic MRI (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2008.