Urinary Incontinence Due to Urethral Sphincter IncompetenceNCT02139956
Assessment of the Internal Urethral Sphincter and the Vagina by Three Dimensional Ultrasound
An observational study of Urinary Incontinence Due to Urethral Sphincter Incompetence, run by Ain Shams University at 1 site in Egypt.
Trial summary
Continent women have an intact internal urethral sphincter that extends from the bladder neck down to the perineal membrane. The internal urethral sphincter is a strong collagen muscle tissue cylinder lined by urothelium. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence Due to Urethral Sphincter Incompetence
- What is being tested?
- ultrasonography
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to May 2014
- How long will I take part?
- 2 Days
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: out patient [clinics] and in patient
Who may be able to join
- signed an informed consent
- patient with stress urinary incontinence
- patient have done a vaginal delivery
- patient with genital prolapse
Who cannot join
- refusal to sign an informed consent
- patient have urinary tract infection
- patient with pregnancy
- patient have vaginal infection
- patient who has undiagnosed vaginal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonic Assessment of the Urethra and the Vagina in Normal Continent Women and Women Suffering From Stress Urinary Incontinence
Continent women have an intact internal urethral sphincter that extends from the bladder neck down to the perineal membrane. The internal urethral sphincter is a strong collagen muscle tissue cylinder lined by urothelium. On ultrasound scanning tissue echo will be detected torn internal urethral sphincter will not stand sudden rise of abdominal pressure. Three dimensional ultrasound assessment of the internal urethral sphincter is very sensitive and specific for the diagnosis of stress urinary incontinence.
Read the detailed description
The internal urethral sphincter used to be said it's a muscular ring but the investigators will visualize by three dimensional ultrasound it's a cylinder in shape and it's the cause of stress urinary incontinence by being torn by stretching the vagina during normal delivery.
- Being tested
- ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
Also called vilson E6, transvaginal probe
open
| Study group | Role | What they receive |
|---|---|---|
| stress urinary incontinence | group 1 women with stress urinary incontinence by ultrasonography Receives: Device: ultrasonography | |
| continent group | group 2 women without stress urinary incontinence by ultrasonography Receives: Device: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the internal urethral sphincter and assesst the extend and degree of the torn internal urethral sphincter
we are going to do 3d ultrasound by transvaginal probe to see the internal urethral sphincter if torn or not and evaluate the morphology of the urethra and pelvic floor structure
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence Due to Urethral Sphincter IncompetenceStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mervat ekky, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139956
- Sponsor's protocol ID
- mekky
- Status last verified
- May 2014
- First submitted
- 6 May 2014
- Last updated
- 16 May 2014
- Results posted
- No
Publications
Kruger JA, Dietz HP, Budgett SC, Dumoulin CL. Comparison between transperineal ultrasound and digital detection of levator ani trauma. Can we improve the odds? Neurourol Urodyn. 2014 Mar;33(3):307-11. doi: 10.1002/nau.22386. Epub 2013 Feb 22.
PubMed 23436235
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Assessment of the Urethra and the Vagina in Normal Continent Women and Women Suffering From Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02139956
- Acronym / sponsor ID
- mekky
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- First posted
- 16 May 2014 (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.
Continent women have an intact internal urethral sphincter that extends from the bladder neck down to the perineal membrane. The internal urethral sphincter is a strong collagen muscle tissue cylinder lined by urothelium. On ultrasound scanning tissue echo will be detected torn internal urethral sphincter will not stand sudden rise of abdominal pressure. Three dimensional ultrasound assessment of the internal urethral sphincter is very sensitive and specific for the diagnosis of stress urinary incontinence.
Detailed description
The internal urethral sphincter used to be said it's a muscular ring but the investigators will visualize by three dimensional ultrasound it's a cylinder in shape and it's the cause of stress urinary incontinence by being torn by stretching the vagina during normal delivery.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stress urinary incontinence | – | Device: ultrasonographygroup 1 women with stress urinary incontinence by ultrasonography |
| continent group | – | Device: ultrasonographygroup 2 women without stress urinary incontinence by ultrasonography |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- out patient [clinics] and in patient
Key inclusion criteria (4 listed)
- signed an informed consent
- patient with stress urinary incontinence
- patient have done a vaginal delivery
- patient with genital prolapse
Key exclusion criteria (5 listed)
- refusal to sign an informed consent
- patient have urinary tract infection
- patient with pregnancy
- patient have vaginal infection
- patient who has undiagnosed vaginal bleeding
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 |
|---|---|---|
| ultrasonographyAlso: vilson E6, transvaginal probeopen | Device | continent group, stress urinary incontinence |
Primary outcome
evaluation of the internal urethral sphincter and assesst the extend and degree of the torn internal urethral sphincter
Time frame: 6 month
we are going to do 3d ultrasound by transvaginal probe to see the internal urethral sphincter if torn or not and evaluate the morphology of the urethra and pelvic floor structure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Results publication: PubMed 23436235Kruger JA, Dietz HP, Budgett SC, Dumoulin CL. Comparison between transperineal ultrasound and digital detection of levator ani trauma. Can we improve the odds? Neurourol Urodyn. 2014 Mar;33(3):307-11. doi: 10.1002/nau.22386. Epub 2013 Feb 22.
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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.
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?
An observational study of Urinary Incontinence Due to Urethral Sphincter Incompetence, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 May 2014. 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 Egypt. 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.
Are results available for this study?
Results are not available in the source record.
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?
evaluation of the internal urethral sphincter and assesst the extend and degree of the torn internal urethral sphincter (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139956, which also lists 1 linked publication.
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 16 May 2014.