Stress Urinary IncontinenceNCT05912491
Transperineal Ultrasonography in Stress Urinary Incontinence
An observational study of Stress Urinary Incontinence, run by Jagiellonian University.
Trial summary
Pelvic organ prolapse (POP) and urinary incontinence (UI) are common female disorders. Accurate diagnosis of the aetiology of pelvic organ descent and prolapse with or without accompanying urination disorders is essential for appropriate therapeutic management. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Transperineal ultrasonography
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 30 May 2023
- Phase
- Observational
- 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 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women hospitalised at the Clinical Department of Gynecological Oncology and Gynecology, University Hospital in Krakow, between July 2012 and July 2015, aged over 18 years. The presence of stress urinary incontinence (SUI) requiring surgical management was the inclusion criterion. The control group included patients without UI referred for surgery due to mild gynaecological disorders. Exclusion criteria included prior surgery for either UI or POP, pelvic tumours that could affect pelvic organ statics, and lack of informed consent to participate in the study.
Who may be able to join
- Stress Urinary Incontinence
Who cannot join
- Failure to obtain endpoint measurements due to lack of cooperation during the ultrasound examination
- Prior surgery for either UI or POP
- Pelvic tumours
- Lack of consent to participate in the study
About this study
Official title: Static and Functional Transperineal Ultrasonography for Identification of Stress Urinary Incontinence
Pelvic organ prolapse (POP) and urinary incontinence (UI) are common female disorders. Accurate diagnosis of the aetiology of pelvic organ descent and prolapse with or without accompanying urination disorders is essential for appropriate therapeutic management. Imaging and functional urodynamic testing are being increasingly used in the diagnosis of this pathology, because precise assessment of the damage to the supporting and ligament apparatus is essential for therapeutic success. Pelvic floor ultrasound can facilitate dynamic assessment of static changes that occur during functional tests. Such assessments can provide additional insights into existing defects, which have explorative value and allow for targeted correction of damage, and may thus indirectly contribute to reduced rates of revision surgeries.
Read the detailed description
Application of the ultrasound transducer to the patient's perineum can visualise three female pelvic compartments, and the images can be frozen to assess the positions of anatomical structures in relation to the pelvic bones and the pre-set planes as well as measure their mutual distances and predefined angles.
The aim of the study was to assess the utility of ultrasound in the detection of UI, particularly for establishing the most useful anatomical and functional parameters and to propose cut-off points for ultrasonographic parameters. The presence of stress urinary incontinence (SUI) requiring surgical management was the inclusion criterion. All patients underwent transperineal ultrasound (TPU) with a Voluson E6 (GE Medical systems, Milwaukee, WI, USA). The probe was oriented to coaxially visualise the pubic symphysis on one side and the anus and rectum on the other side of the 2D image. When all three compartments could not be visualised in one image, one image showing the anterior and medial compartments and another image showing the medial and posterior compartments were obtained instead. Next, 3D/4D ultrasound was performed to obtain an image in the coronal plane at the level of the arms of the levator ani muscle, showing the pubic symphysis and the anus. All measurements were performed in three states: during pelvic muscle relaxation, during Valsalva manoeuvre, and during perineal squeezing. The following quantitative parameters were assessed and compared across two arms of the study (with and without SUI):
- Bladder-symphysis distance (BSD) - measured as the distance between the urine bladder neck and the symphysis,
- Alpha angle - the angle between the axis of the proximal urethra and the x-axis of the symphysis pubis (central line),
- Beta angle - the angle between the line parallel to the proximal urethra and the line parallel to the distal axis of urethra,
- Gamma angle - the angle between the lower margin of the symphysis pubis and the urinary bladder neck),
- Retrovesical angle (RVA) - the angle between the axis of the proximal urethra and the tangent line to the lowest part of the posterior wall of the urinary bladder,
- Mean urethral diameter - the sum of the urethral diameters at three points (proximal, central, and distal parts) divided by 3.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Transperineal ultrasonography
- Keywords
- stress urinary incontinence, transperineal ultrasound
- 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.
Transperineal ultrasonographyDiagnostic test
Transperineal ultrasound (TPU) with a Voluson E6 (GE Medical systems, Milwaukee, WI, USA). The probe was oriented to coaxially visualise the pubic symphysis on one side and the anus and rectum on the other side of the 2D image. Next, 3D/4D ultrasound was performed to obtain an image in the coronal plane at the level of the arms of the levator ani muscle, showing the pubic symphysis and the anus. All measurements were performed in three states: during pelvic muscle relaxation, during Valsalva manoeuvre, and during perineal squeezing.
| Study group | Role | What they receive |
|---|---|---|
| Urinary stress incontinence (UI) | Women with clinical symptoms of stress urinary incontinence Receives: Diagnostic Test: Transperineal ultrasonography | |
| No Urinary stress incontinence (no-UI) | Women without clinical symptoms of stress urinary incontinence Receives: Diagnostic Test: Transperineal ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder-symphysis distance (BSD)
Distance in mm between the urine bladder neck and the symphysis
Measured: 36 months
Alpha angle
Measurement of the angle in degrees between the axis of the proximal urethra and the x-axis of the symphysis pubis (central line)
Measured: 36 months
Beta angle
Measurement of the angle in degrees between the line parallel to the proximal urethra and the line parallel to the distal axis of urethra
Measured: 36 months
Gamma angle
Measurement of the angle in degrees between the lower margin of the symphysis pubis and the urinary bladder neck
Measured: 36 months
Retrovesical angle (RVA)
Measurement of the angle in degrees between the axis of the proximal urethra and the tangent line to the lowest part of the posterior wall of the urinary bladder
Measured: 36 months
Mean urethral diameter
Mean urethral diameter in mm obtained by summing the urethral diameters at three points (proximal, mid, and distal) and dividing the sum obtained by 3
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2012
- Primary completion1 Jul 2015
- Study completion30 May 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Kazimierz Pitynski, Ph.D., Prof., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912491
- Sponsor's protocol ID
- KBET/228/B/2010
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static and Functional Transperineal Ultrasonography for Identification of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05912491
- Acronym / sponsor ID
- KBET/228/B/2010
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, transperineal ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- 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.
Pelvic organ prolapse (POP) and urinary incontinence (UI) are common female disorders. Accurate diagnosis of the aetiology of pelvic organ descent and prolapse with or without accompanying urination disorders is essential for appropriate therapeutic management. Imaging and functional urodynamic testing are being increasingly used in the diagnosis of this pathology, because precise assessment of the damage to the supporting and ligament apparatus is essential for therapeutic success. Pelvic floor ultrasound can facilitate dynamic assessment of static changes that occur during functional tests. Such assessments can provide additional insights into existing defects, which have explorative value and allow for targeted correction of damage, and may thus indirectly contribute to reduced rates of revision surgeries.
Detailed description
Application of the ultrasound transducer to the patient's perineum can visualise three female pelvic compartments, and the images can be frozen to assess the positions of anatomical structures in relation to the pelvic bones and the pre-set planes as well as measure their mutual distances and predefined angles.
The aim of the study was to assess the utility of ultrasound in the detection of UI, particularly for establishing the most useful anatomical and functional parameters and to propose cut-off points for ultrasonographic parameters. The presence of stress urinary incontinence (SUI) requiring surgical management was the inclusion criterion. All patients underwent transperineal ultrasound (TPU) with a Voluson E6 (GE Medical systems, Milwaukee, WI, USA). The probe was oriented to coaxially visualise the pubic symphysis on one side and the anus and rectum on the other side of the 2D image. When all three compartments could not be visualised in one image, one image showing the anterior and medial compartments and another image showing the medial and posterior compartments were obtained instead. Next, 3D/4D ultrasound was performed to obtain an image in the coronal plane at the level of the arms of the levator ani muscle, showing the pubic symphysis and the anus. All measurements were performed in three states: during pelvic muscle relaxation, during Valsalva manoeuvre, and during perineal squeezing. The following quantitative parameters were assessed and compared across two arms of the study (with and without SUI):
- Bladder-symphysis distance (BSD) - measured as the distance between the urine bladder neck and the symphysis,
- Alpha angle - the angle between the axis of the proximal urethra and the x-axis of the symphysis pubis (central line),
- Beta angle - the angle between the line parallel to the proximal urethra and the line parallel to the distal axis of urethra,
- Gamma angle - the angle between the lower margin of the symphysis pubis and the urinary bladder neck),
- Retrovesical angle (RVA) - the angle between the axis of the proximal urethra and the tangent line to the lowest part of the posterior wall of the urinary bladder,
- Mean urethral diameter - the sum of the urethral diameters at three points (proximal, central, and distal parts) divided by 3.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinary stress incontinence (UI) | – | Diagnostic Test: Transperineal ultrasonographyWomen with clinical symptoms of stress urinary incontinence |
| No Urinary stress incontinence (no-UI) | – | Diagnostic Test: Transperineal ultrasonographyWomen without clinical symptoms of stress urinary incontinence |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women hospitalised at the Clinical Department of Gynecological Oncology and Gynecology, University Hospital in Krakow, between July 2012 and July 2015, aged over 18 years. The presence of stress urinary incontinence (SUI) requiring surgical management was the inclusion criterion. The control group included patients without UI referred for surgery due to mild gynaecological disorders. Exclusion criteria included prior surgery for either UI or POP, pelvic tumours that could affect pelvic organ statics, and lack of informed consent to participate in the study.
Key inclusion criteria (1 listed)
- Stress Urinary Incontinence
Key exclusion criteria (4 listed)
- Failure to obtain endpoint measurements due to lack of cooperation during the ultrasound examination
- Prior surgery for either UI or POP
- Pelvic tumours
- Lack of consent to participate in the study
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 |
|---|---|---|
| Transperineal ultrasonographyTransperineal ultrasound (TPU) with a Voluson E6 (GE Medical systems, Milwaukee, WI, USA). The probe was oriented to coaxially visualise the pubic symphysis on one side and the anus and rectum on the other side of the 2D image. Next, 3D/4D ultrasound was performed to obtain an image in the coronal plane at the level of the arms of the levator ani muscle, showing the pubic symphysis and the anus. All measurements were performed in three states: during pelvic muscle relaxation, during Valsalva manoeuvre, and during perineal squeezing. | Diagnostic test | No Urinary stress incontinence (no-UI), Urinary stress incontinence (UI) |
Primary outcome
Bladder-symphysis distance (BSD)
Time frame: 36 months
Distance in mm between the urine bladder neck and the symphysis
Alpha angle
Time frame: 36 months
Measurement of the angle in degrees between the axis of the proximal urethra and the x-axis of the symphysis pubis (central line)
Beta angle
Time frame: 36 months
Measurement of the angle in degrees between the line parallel to the proximal urethra and the line parallel to the distal axis of urethra
Gamma angle
Time frame: 36 months
Measurement of the angle in degrees between the lower margin of the symphysis pubis and the urinary bladder neck
Retrovesical angle (RVA)
Time frame: 36 months
Measurement of the angle in degrees between the axis of the proximal urethra and the tangent line to the lowest part of the posterior wall of the urinary bladder
Mean urethral diameter
Time frame: 36 months
Mean urethral diameter in mm obtained by summing the urethral diameters at three points (proximal, mid, and distal) and dividing the sum obtained by 3
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 22 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Kazimierz Pitynski, Ph.D., Prof. study chair
Jagiellonian University
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Jagiellonian University.
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 1 inclusion and 4 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Bladder-symphysis distance (BSD) (time frame: 36 months). The study lists 6 primary outcomes in all. 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 22 Jun 2023.