Pelvic Floor DisordersNCT04561843
3D Transperineal Ultrasound of the Pelvic Floor Muscles in Women With Pelvic Floor Disorders: A Cross-sectional Study.
An observational study of Pelvic Floor Disorders, run by Assiut University.
Trial summary
The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- pelvic floor ultrasound
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jun 2022
- How long will I take part?
- 6 Months
- 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 21 to 50 years
- Women only
- Adult
Study population: Women complaining of any of the pelvic floor disorder symptoms such as: Pelvic organ prolapse (POP), Stress urinary incontinence (SUI), urgency symptoms of obstructed defecation, fecal incontinence (FI), pelvic pain, and/or sexual problems.
Who may be able to join
- Women complaining of any of the pelvic floor disorder symptoms.
Who cannot join
- women with a history of chronic intestinal disease (Crohn's disease, ulcerative colitis), acute gastroenteritis within the week preceding consultation women who underwent any surgical or diagnostic procedure involving the anal canal
Trial locations and contacts
No sites are listed yet.
Abdalla Mohammed Sayed, master contact
About this study
The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.
Read the detailed description
The prevalence of Pelvic floor dysfunction is high, affecting millions of women worldwide in different conditions (social, sexual, physical, psychological, domestic relationships, financial, etc.), many people still have no, limited knowledge, or awareness of pelvic floor health and so do not have, or seek how to prevent or correct these disorders . This dysfunction may be presented as pelvic organ prolapse, stress urinary incontinence, fecal incontinence , chronic pelvic pain, sexual problems, and/or chronic constipation . Assessment of pelvic floor muscle activity plays a major role in Urogynecology and physiotherapy as a part of the conservative treatment of pelvic floor disorders (PFD) . Presence of Levator avulsion is a major risk factor for female pelvic organ prolapse (POP) and recurrence after surgical correction . This dysfunction can be diagnosed clinically using vaginal palpation . Palpation is subjective, less reproducible, and difficult to teach than imaging methods [6]. Studies that used ultrasound for assessment of pelvic floor muscle activity and strength are still few . The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.
- Conditions
- Pelvic Floor Disorders
- Being tested
- pelvic floor ultrasound
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor ultrasoundDiagnostic test
2D and 3D trans-perineum ultrasound examinations will be performed by single examiner who was blind to clinical data, using a GE Voluson 730 machine (GE Medical System Kretz Technik, Zipf, Austria) with a RAB 4-8 MHz curved array volume transducer. In the supine position, with flexed and slightly abducted hips after urine voiding. The transducer was placed on the perineum, in the mid sagittal plane with minimal pressure being applied after covering it with an un-powdered glove or thin plastic wrap for hygienic reasons
| Study group | Role | What they receive |
|---|---|---|
| case group | Women complaining of any of the pelvic floor disorder symptoms such as: Pelvic organ prolapse (POP), Stress urinary incontinence (SUI), urgency symptoms of obstructed defecation, fecal incontinence (FI), pelvic pain, and/or sexual problems. Receives: Diagnostic Test: pelvic floor ultrasound | |
| control group | Women not complaining of any of the pelvic floor disorder symptoms Receives: Diagnostic Test: pelvic floor ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic floor muscle function.
The hiatal antro-posterior distance (LHap) between the inferior margin of the pubic symphysis and the pubo-rectalis sling was measured at rest, on maximum contraction, and at valsalva. The percentage difference decrease [valuerest valuecontraction/ valuerest] for contraction is calculated as a measurement of pelvic floor muscle function.
Measured: 15 miutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 91 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sief el eslam Ahmed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561843
- Sponsor's protocol ID
- AUG2020
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Transperineal Ultrasound of the Pelvic Floor Muscles in Women With Pelvic Floor Disorders: A Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT04561843
- Acronym / sponsor ID
- AUG2020
- Conditions
- Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 24 Sep 2020 (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.
The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.
Detailed description
The prevalence of Pelvic floor dysfunction is high, affecting millions of women worldwide in different conditions (social, sexual, physical, psychological, domestic relationships, financial, etc.), many people still have no, limited knowledge, or awareness of pelvic floor health and so do not have, or seek how to prevent or correct these disorders . This dysfunction may be presented as pelvic organ prolapse, stress urinary incontinence, fecal incontinence , chronic pelvic pain, sexual problems, and/or chronic constipation . Assessment of pelvic floor muscle activity plays a major role in Urogynecology and physiotherapy as a part of the conservative treatment of pelvic floor disorders (PFD) . Presence of Levator avulsion is a major risk factor for female pelvic organ prolapse (POP) and recurrence after surgical correction . This dysfunction can be diagnosed clinically using vaginal palpation . Palpation is subjective, less reproducible, and difficult to teach than imaging methods [6]. Studies that used ultrasound for assessment of pelvic floor muscle activity and strength are still few . The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: pelvic floor ultrasoundWomen complaining of any of the pelvic floor disorder symptoms such as: Pelvic organ prolapse (POP), Stress urinary incontinence (SUI), urgency symptoms of obstructed defecation, fecal incontinence (FI), pelvic pain, and/or sexual problems. |
| control group | – | Diagnostic Test: pelvic floor ultrasoundWomen not complaining of any of the pelvic floor disorder symptoms |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women complaining of any of the pelvic floor disorder symptoms such as: Pelvic organ prolapse (POP), Stress urinary incontinence (SUI), urgency symptoms of obstructed defecation, fecal incontinence (FI), pelvic pain, and/or sexual problems.
Key inclusion criteria (1 listed)
- Women complaining of any of the pelvic floor disorder symptoms.
Key exclusion criteria (1 listed)
- women with a history of chronic intestinal disease (Crohn's disease, ulcerative colitis), acute gastroenteritis within the week preceding consultation women who underwent any surgical or diagnostic procedure involving the anal canal
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 |
|---|---|---|
| pelvic floor ultrasound2D and 3D trans-perineum ultrasound examinations will be performed by single examiner who was blind to clinical data, using a GE Voluson 730 machine (GE Medical System Kretz Technik, Zipf, Austria) with a RAB 4-8 MHz curved array volume transducer. In the supine position, with flexed and slightly abducted hips after urine voiding. The transducer was placed on the perineum, in the mid sagittal plane with minimal pressure being applied after covering it with an un-powdered glove or thin plastic wrap for hygienic reasons | Diagnostic test | case group, control group |
Primary outcome
pelvic floor muscle function.
Time frame: 15 miutes
The hiatal antro-posterior distance (LHap) between the inferior margin of the pubic symphysis and the pubo-rectalis sling was measured at rest, on maximum contraction, and at valsalva. The percentage difference decrease [valuerest valuecontraction/ valuerest] for contraction is calculated as a measurement of pelvic floor muscle function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Abdalla Mohammed Sayed, master contact
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by Assiut 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 1 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 28 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sief Ali, MD (+201004971596, SiefAli73@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pelvic floor muscle function. (time frame: 15 miutes). 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 28 Sep 2020.