Pelvic Floor, ObstetricNCT03241836
Trans-perineal Ultrasound & Dynamic Pelvic Magnetic Resonance Imaging in Assessment of Pelvic Floor Dysfunction.
An observational study of Pelvic Floor, Obstetric, run by Assiut University.
Trial summary
Pelvic floor failure is a common disorder that can seriously jeopardize woman's quality of life by causing urinary, fecal incontinence, difficult defecation and pelvic pain. Multiple congenital and acquired risk factors are associated with pelvic floor failure including altered collagen metabolism, female sex, vaginal… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Pelvic Floor, Obstetric
- What is being tested?
- trans-perineal ultrasonography
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Apr 2022
- 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: female patients in child bearing period (20-39 yrs old) with or without symptoms of pelvic floor failure
- Inclusion criteria: asmptomatic and symptomatic female Patients in child bearing period 40 days after vaginal delivery and cesarean section.
- Exclusion criteria: patients with previous pelvic floor surgery.
About this study
Official title: Role of Trans-perineal Ultrasonography on Basis of Dynamic Pelvic Magnetic Resonance Imaging in Diagnosis of Female Pelvic Floor Dysfunction
Pelvic floor failure is a common disorder that can seriously jeopardize woman's quality of life by causing urinary, fecal incontinence, difficult defecation and pelvic pain. Multiple congenital and acquired risk factors are associated with pelvic floor failure including altered collagen metabolism, female sex, vaginal delivery, menopause, and advanced age. A complex variety of fascial and muscular lesions that range from stretching, insertion detachment, denervation atrophy, and combinations of pelvic floor relaxation to pelvic organ prolapse may manifest in a single patient.
The prevalence of pelvic floor dysfunction increases with age. It is approximately 9.7% in child bearing period (20-39 yrs), while it reaches up to 49.7% by 80 yrs and older.
Read more
Thorough preoperative assessment of pelvic floor failure is necessary to reduce the rate of relapse, which is reported to be as high as 30%.
MR imaging is a powerful tool that enables radiologists to comprehensively evaluate pelvic anatomic and functional abnormalities, thus helping surgeons provide appropriate treatment and avoid repeat operations.
Real time 2D trans-perineal ultrasound is emerging as an exciting new technique for pelvic floor assessment. It has advantage of providing a global view of the entire pelvic floor, from the symphysis to the ano-rectum, and includes the lower aspects of the levator ani muscle, in addition to its lower costs and greater accessibility; also sonographic imaging is more useful in the clinical environment, and generally better tolerated than MRI.
Read the detailed description
135 female patients in child bearing period (20-39 yrs) will undergo trans-perineal US and dynamic pelvic MRI; 40 days after vaginal delivery or cesarean section for asymptomatic and symptomatic cases.
Revision after six months for cases with sonongraphic or MRI findings. after obtaining an informed written consent and approval of the ethical committee of faculty of medicine of Assiut University.
- Inclusion criteria: asmptomatic and symptomatic female Patients in child bearing period 40 days after vaginal delivery and cesarean section.
- Exclusion criteria: patients with previous pelvic floor surgery.
Patient preparation
For trans-perineal US:
- Patient is positioned in dorsal lithotomy position, with the hips flexed and slightly abducted and after bladder and bowel emptying. The pelvic tilt can be improved by asking the patient to place their heels as close as possible to the but¬tocks and move hips towards the heels.
For MRI:
- Patient is positioned in supine position and using pelvic coil after bladder and bowel emptying.
Method:
- trans-perineal US: B mode capable 2D ultrasound system with cine loop function, 3.5-6.0 MHz curved array transducer. A mid-sagittal and axial views is obtained by placing a transducer on the perineum (Parting of the labia can improve image quality).
- Dynamic MRI:
Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes:
Analysis of anatomic damage on axial, coronal and sagittal fast spin-echo (FSE) T2-weighted images.
Functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation.
- Conditions
- Pelvic Floor, Obstetric
- Being tested
- trans-perineal ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-perineal ultrasonographyDiagnostic test
Also called dynamic pelvic MRI
accuracy of trans perineal ultrasonography in identification of female pelvic floor dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study startMay 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: 3Dtransvaginal probe is not available at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor, ObstetricStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AShassan, Assiut University
- Investigators
- alzahraa sayed hassan, a.lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241836
- Sponsor's protocol ID
- TPUS& MRI female pelvic floor
- Status last verified
- Feb 2018
- First submitted
- 1 Aug 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Trans-perineal Ultrasonography on Basis of Dynamic Pelvic Magnetic Resonance Imaging in Diagnosis of Female Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT03241836
- Acronym / sponsor ID
- TPUS& MRI female pelvic floor
- Conditions
- Pelvic Floor, Obstetric
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 3Dtransvaginal probe is not available at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 8 Aug 2017 (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 floor failure is a common disorder that can seriously jeopardize woman's quality of life by causing urinary, fecal incontinence, difficult defecation and pelvic pain. Multiple congenital and acquired risk factors are associated with pelvic floor failure including altered collagen metabolism, female sex, vaginal delivery, menopause, and advanced age. A complex variety of fascial and muscular lesions that range from stretching, insertion detachment, denervation atrophy, and combinations of pelvic floor relaxation to pelvic organ prolapse may manifest in a single patient.
The prevalence of pelvic floor dysfunction increases with age. It is approximately 9.7% in child bearing period (20-39 yrs), while it reaches up to 49.7% by 80 yrs and older.
Thorough preoperative assessment of pelvic floor failure is necessary to reduce the rate of relapse, which is reported to be as high as 30%.
MR imaging is a powerful tool that enables radiologists to comprehensively evaluate pelvic anatomic and functional abnormalities, thus helping surgeons provide appropriate treatment and avoid repeat operations.
Real time 2D trans-perineal ultrasound is emerging as an exciting new technique for pelvic floor assessment. It has advantage of providing a global view of the entire pelvic floor, from the symphysis to the ano-rectum, and includes the lower aspects of the levator ani muscle, in addition to its lower costs and greater accessibility; also sonographic imaging is more useful in the clinical environment, and generally better tolerated than MRI.
Detailed description
135 female patients in child bearing period (20-39 yrs) will undergo trans-perineal US and dynamic pelvic MRI; 40 days after vaginal delivery or cesarean section for asymptomatic and symptomatic cases.
Revision after six months for cases with sonongraphic or MRI findings. after obtaining an informed written consent and approval of the ethical committee of faculty of medicine of Assiut University.
- Inclusion criteria: asmptomatic and symptomatic female Patients in child bearing period 40 days after vaginal delivery and cesarean section.
- Exclusion criteria: patients with previous pelvic floor surgery.
Patient preparation
For trans-perineal US:
- Patient is positioned in dorsal lithotomy position, with the hips flexed and slightly abducted and after bladder and bowel emptying. The pelvic tilt can be improved by asking the patient to place their heels as close as possible to the but¬tocks and move hips towards the heels.
For MRI:
- Patient is positioned in supine position and using pelvic coil after bladder and bowel emptying.
Method:
- trans-perineal US: B mode capable 2D ultrasound system with cine loop function, 3.5-6.0 MHz curved array transducer. A mid-sagittal and axial views is obtained by placing a transducer on the perineum (Parting of the labia can improve image quality).
- Dynamic MRI:
Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes:
Analysis of anatomic damage on axial, coronal and sagittal fast spin-echo (FSE) T2-weighted images.
Functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female patients in child bearing period (20-39 yrs old) with or without symptoms of pelvic floor failure
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 |
|---|---|---|
| trans-perineal ultrasonographyAlso: dynamic pelvic MRIaccuracy of trans perineal ultrasonography in identification of female pelvic floor dysfunction | Diagnostic test | – |
Primary outcome
accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction
Time frame: four years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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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.
alzahraa sayed hassan, a.lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor, Obstetric, 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?
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: withdrawn, as of the sponsor's last update on 27 Feb 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
accuracy of trans-perineal ultrasonography in assessment of pelvic floor dysfunction (time frame: four 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 27 Feb 2018.