Pelvic Organ ProlapseNCT03857724
Three-dimensional Ultrasound Assessment in Cases of Prolapse Surgeries
A study testing prolapse surgery in people with Pelvic Organ Prolapse, run by Assiut University at 1 site in Egypt.
Trial summary
The levator ani muscle seems to play a key role in pelvic floor dysfunction. This muscle has two major components, the pubovisceral (including the pubococcygeus and puborectalis muscles) and the iliococcygeal muscles.Major levator ani defects are associated with pelvic organ prolapse (POP) and POP recurrence Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- prolapse surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2019to Sep 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Arabic female that is able to understand the instructions and the questionnaires that will be given II. Apical prolapse Stage 2-4 (according to POP-Q)(30,33) III. Sexually active (at least 3 times every month)
Who cannot join
- Pregnancy
- Postpartum women during the 1st 6 months postpartum
- Human papillomavirus vulvar disease (condyloma acuminata)
- Patient unfit for surgery
- Previous pelvic reconstruction surgery.
- Factors affecting healing process as uncontrolled diabetes, steroid therapy, on chemotherapy,….. etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Three-dimensional Ultrasound Assessment of Cases With Apical Prolapse Surgeries. A Prospective Cohort Study
The levator ani muscle seems to play a key role in pelvic floor dysfunction. This muscle has two major components, the pubovisceral (including the pubococcygeus and puborectalis muscles) and the iliococcygeal muscles.Major levator ani defects are associated with pelvic organ prolapse (POP) and POP recurrence
Read the detailed description
The aetiology of female pelvic organ prolapse (FPOP) is complex and likely due to a combination of factors. Genetics, race, aging and menopause, obesity and conditions associated with a chronically increased intra-abdominal pressure such as chronic obstructive pulmonary disease as well as childbirth trauma have been implicated. Delivery-related trauma to the pubovisceral muscle is common and obviously associated with female pelvic organ prolapse.
It is a common problem with an incidence as high as 40%, and 10-20% of women will require surgery for prolapse at least once in their lifetime.
The levator hiatus defines the 'hernial portal' through which FPOP develops. Childbirth clearly leads to an enlargement of the levator hiatus, even in the absence of levator trauma.
And the levator hiatal dimensions are strongly associated with FPOP and with prolapse recurrence Enlargement of the levator hiatus is more likely to be the cause rather than the effect of FPOP. Alterations of the levator hiatus morphology following delivery have been demonstrated using magnetic resonance imaging (MRI) and more recently, three-dimensional (3D) ultrasound imaging Magnetic resonance imaging (MRI) has been shown to visualize levator ani defects effectively, but in recent years, translabial 3- and 4-dimensional (3D/4D) ultrasound has shown to provide valuable information on biometrical properties of the pelvic floor and morphology of the levator ani muscle.And recently three-dimensional ultrasonography is an alternative for MRI in detecting levator defects.
Currently, technologic advances in 3D ultrasonography allow access to the arbitrarily defined planes anywhere within ultrasound volume data and permit direct imaging of the entire levator hiatus.
Translabial three-dimensional ultrasonography has practical advantages because it is less expensive, easily accessible, and more readily available for gynecologists.
3D-Ultrasound in urogynecology could be helpful in diagnosing of urinary incontinence and urethral hypermobility, to document pelvic floor anatomy and to assess anatomic and functional changes before and after gynecologic surgery.
The objective of our research was to detect levator ani defects in women with POP before and after apical prolapse surgeries and if they will be corrected after the operation or not.
The secondary objective was to 1)detect the most appropriate surgical procedure in restoring the dimensions of the hiatal area.
2)Correlate between the levator ani defects and the complains, quality of life questionnaires, clinical examination of the patient before and after the surgery.
3)The role of 3D-Ultrasound in diagnosing the pelvic floor defects and targeting the Surgical procedure to restore the defects.
4)Introduce and stress on POP-Q system into Assuit general hospital and Abuteeg Hospital as it will be used to evaluate all cases both pre-operatively and during post-operative follow up being the standard method for evaluating cases of pelvic organ prolapse.
Objective cure was defined as the: absence of the prolapse as indicated by a POP-Q stage of 0-1.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- prolapse surgery
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolapse surgeryProcedure or surgery
prolapse surgery
| Study group | Role | What they receive |
|---|---|---|
| prolapse surgery | Experimental | Not described Receives: Procedure: prolapse surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study startJul 2019 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Yacoub Shafeek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857724
- Sponsor's protocol ID
- 3D ULTRASOUND
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse? Eur J Obstet Gynecol Reprod Biol. 1999 May;84(1):23-5. doi: 10.1016/s0301-2115(99)00002-0.
PubMed 10413222Lin KL, Juan YS, Chou SH, Long CY. Ultrasonographic Assessment with Three-Dimensional Mode of the Urethral Compression Effect following Sling Surgery with and without Mesh Surgery. Biomed Res Int. 2019 Jan 6;2019:8285351. doi: 10.1155/2019/8285351. eCollection 2019.
PubMed 30723744
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Three-dimensional Ultrasound Assessment of Cases With Apical Prolapse Surgeries. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03857724
- Acronym / sponsor ID
- 3D ULTRASOUND
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 28 Feb 2019 (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 levator ani muscle seems to play a key role in pelvic floor dysfunction. This muscle has two major components, the pubovisceral (including the pubococcygeus and puborectalis muscles) and the iliococcygeal muscles.Major levator ani defects are associated with pelvic organ prolapse (POP) and POP recurrence
Detailed description
The aetiology of female pelvic organ prolapse (FPOP) is complex and likely due to a combination of factors. Genetics, race, aging and menopause, obesity and conditions associated with a chronically increased intra-abdominal pressure such as chronic obstructive pulmonary disease as well as childbirth trauma have been implicated. Delivery-related trauma to the pubovisceral muscle is common and obviously associated with female pelvic organ prolapse.
It is a common problem with an incidence as high as 40%, and 10-20% of women will require surgery for prolapse at least once in their lifetime.
The levator hiatus defines the 'hernial portal' through which FPOP develops. Childbirth clearly leads to an enlargement of the levator hiatus, even in the absence of levator trauma.
And the levator hiatal dimensions are strongly associated with FPOP and with prolapse recurrence Enlargement of the levator hiatus is more likely to be the cause rather than the effect of FPOP. Alterations of the levator hiatus morphology following delivery have been demonstrated using magnetic resonance imaging (MRI) and more recently, three-dimensional (3D) ultrasound imaging Magnetic resonance imaging (MRI) has been shown to visualize levator ani defects effectively, but in recent years, translabial 3- and 4-dimensional (3D/4D) ultrasound has shown to provide valuable information on biometrical properties of the pelvic floor and morphology of the levator ani muscle.And recently three-dimensional ultrasonography is an alternative for MRI in detecting levator defects.
Currently, technologic advances in 3D ultrasonography allow access to the arbitrarily defined planes anywhere within ultrasound volume data and permit direct imaging of the entire levator hiatus.
Translabial three-dimensional ultrasonography has practical advantages because it is less expensive, easily accessible, and more readily available for gynecologists.
3D-Ultrasound in urogynecology could be helpful in diagnosing of urinary incontinence and urethral hypermobility, to document pelvic floor anatomy and to assess anatomic and functional changes before and after gynecologic surgery.
The objective of our research was to detect levator ani defects in women with POP before and after apical prolapse surgeries and if they will be corrected after the operation or not.
The secondary objective was to 1)detect the most appropriate surgical procedure in restoring the dimensions of the hiatal area.
2)Correlate between the levator ani defects and the complains, quality of life questionnaires, clinical examination of the patient before and after the surgery.
3)The role of 3D-Ultrasound in diagnosing the pelvic floor defects and targeting the Surgical procedure to restore the defects.
4)Introduce and stress on POP-Q system into Assuit general hospital and Abuteeg Hospital as it will be used to evaluate all cases both pre-operatively and during post-operative follow up being the standard method for evaluating cases of pelvic organ prolapse.
Objective cure was defined as the: absence of the prolapse as indicated by a POP-Q stage of 0-1.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prolapse surgery | Experimental | Procedure: prolapse surgery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Arabic female that is able to understand the instructions and the questionnaires that will be given II. Apical prolapse Stage 2-4 (according to POP-Q)(30,33) III. Sexually active (at least 3 times every month)
Key exclusion criteria (6 listed)
- Pregnancy
- Postpartum women during the 1st 6 months postpartum
- Human papillomavirus vulvar disease (condyloma acuminata)
- Patient unfit for surgery
- Previous pelvic reconstruction 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 |
|---|---|---|
| prolapse surgeryprolapse surgery | Procedure or surgery | prolapse surgery |
Primary outcome
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
Time frame: 2 years
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Results publication: PubMed 10413222Rinne KM, Kirkinen PP. What predisposes young women to genital prolapse? Eur J Obstet Gynecol Reprod Biol. 1999 May;84(1):23-5. doi: 10.1016/s0301-2115(99)00002-0.
- Results publication: PubMed 30723744Lin KL, Juan YS, Chou SH, Long CY. Ultrasonographic Assessment with Three-Dimensional Mode of the Urethral Compression Effect following Sling Surgery with and without Mesh Surgery. Biomed Res Int. 2019 Jan 6;2019:8285351. doi: 10.1155/2019/8285351. eCollection 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prolapse surgery in people with Pelvic Organ Prolapse, run by Assiut 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 1 inclusion and 6 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 5 Mar 2019. 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?
Contact Alaa Eldin Yousef (01222442140, alaaeldinabdelhamid60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levator hiatus area in cm2 in women with POP before and after apical prolapse surgeries. (time frame: 2 years). 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 NCT03857724, which also lists 2 linked publications.
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 5 Mar 2019.