Pelvic Floor DisordersNCT03456310
Transperineal US on Basis of MRI in Female Pelvic Floor Dysfunction
A study testing transperineal ultrasound in people with Pelvic Floor Disorders, run by Assiut University.
Trial summary
Pelvic floor failure is a common disorder that can seriously jeopardize a woman's quality of life by causing urinary and fecal incontinence, difficult defecation and pelvic pain. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- transperineal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Feb 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- asmptomatic and symptomatic female Patients in child bearing period 40 days after vaginal delivery and cesarean section.
Who cannot join
- patients with previous pelvic floor surgery.
About this study
Official title: Role of Transperineal Ultrasonography on Basis of Dynamic Pelvic MRI in Diagnosis of Female Pelvic Floor Dysfunction.
Pelvic floor failure is a common disorder that can seriously jeopardize a woman's quality of life by causing urinary and 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%.
Read more
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 magnetic resonance imaging.
Read the detailed description
Patient: 135 female patients in child bearing period (20-39 yrs) will undergo trans-perineal ultrasound 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: asymptomatic 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 buttocks 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, a 3.5-6.0 MHz curved array transducer. At women health hospital. A mid-sagittal and axial views is obtained by placing a transducer on the perineum (Parting of the labia can improve image quality). The following measures will be obtained: Hiatus diameter, bladder neck descent, and descent of other pelvic organs in relation to reference line (parallel to lower part of public bone).
- Dynamic MRI:
Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes:
analysis of anatomic damage on axial fast spin-echo (FSE) T2-weighted images. then sagittal and coronal (FSE) T2-weighted are obtained.
functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation to show descent of pelvic organs and pelvic floor relaxation or weakness.
- Conditions
- Pelvic Floor Disorders
- Being tested
- transperineal 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.
transperineal ultrasoundDiagnostic test
Also called dynamic pelvic MRI
trans-perineal US: B mode capable 2D ultrasound system with cine loop function, a 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 fast spin-echo (FSE) T2-weighted images. then sagittal and coronal (FSE) T2-weighted are obtained.
functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation.
| Study group | Role | What they receive |
|---|---|---|
| Trans-perineal ultrasound | Experimental | Transperineal ultrasonography is done by 2D ultrasound machine, curved probe is placed in the perineum, mid sagittal and axial views are obtained Then it's accuracy is assessed according to findings on dynamic pelvic MRI . Receives: Diagnostic Test: transperineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
role of trans-perineal ultrasound in diagnosis of pelvic floor dysfunction
accuracy of trans-perineal ultrasound in detection and assessment of female pelvic floor dysfunction
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study startSep 2018 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AShassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456310
- Sponsor's protocol ID
- TPUS MRI PELVIC FLOOR
- Status last verified
- Aug 2018
- First submitted
- 21 Feb 2018
- Last updated
- 14 Aug 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 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transperineal Ultrasonography on Basis of Dynamic Pelvic MRI in Diagnosis of Female Pelvic Floor Dysfunction.
- ClinicalTrials.gov ID
- NCT03456310
- Acronym / sponsor ID
- TPUS MRI PELVIC FLOOR
- Conditions
- Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 7 Mar 2018 (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 a woman's quality of life by causing urinary and 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 magnetic resonance imaging.
Detailed description
Patient: 135 female patients in child bearing period (20-39 yrs) will undergo trans-perineal ultrasound 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: asymptomatic 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 buttocks 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, a 3.5-6.0 MHz curved array transducer. At women health hospital. A mid-sagittal and axial views is obtained by placing a transducer on the perineum (Parting of the labia can improve image quality). The following measures will be obtained: Hiatus diameter, bladder neck descent, and descent of other pelvic organs in relation to reference line (parallel to lower part of public bone).
- Dynamic MRI:
Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes:
analysis of anatomic damage on axial fast spin-echo (FSE) T2-weighted images. then sagittal and coronal (FSE) T2-weighted are obtained.
functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation to show descent of pelvic organs and pelvic floor relaxation or weakness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans-perineal ultrasound | Experimental | Diagnostic Test: transperineal ultrasoundTransperineal ultrasonography is done by 2D ultrasound machine, curved probe is placed in the perineum, mid sagittal and axial views are obtained Then it's accuracy is assessed according to findings on dynamic pelvic MRI . |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- asmptomatic and symptomatic female Patients in child bearing period 40 days after vaginal delivery and cesarean section.
Key exclusion criteria (1 listed)
- patients with previous pelvic floor surgery.
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 ultrasoundAlso: dynamic pelvic MRItrans-perineal US: B mode capable 2D ultrasound system with cine loop function, a 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 fast spin-echo (FSE) T2-weighted images. then sagittal and coronal (FSE) T2-weighted are obtained. functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation. | Diagnostic test | Trans-perineal ultrasound |
Primary outcome
role of trans-perineal ultrasound in diagnosis of pelvic floor dysfunction
Time frame: 4 years
accuracy of trans-perineal ultrasound in detection and assessment of female pelvic floor dysfunction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
Related trials for Pelvic Floor Disorders
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
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.
Questions about this trial
What is this clinical trial studying?
A study testing transperineal ultrasound in people with 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 14 Aug 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?
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?
role of trans-perineal ultrasound in diagnosis of pelvic floor dysfunction (time frame: 4 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 14 Aug 2018.