Pelvic Organ ProlapseNCT03146195
The 3D Reconstruction Research of Pelvic Organ Prolapse Disease
An observational study of Pelvic Organ Prolapse and Normal Pelvic Floor, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Female pelvic organ prolapse (FPOP) is one of the main diseases affecting the quality of life of middle aged and elderly women in non-neoplastic diseases. An aging population makes the incidence of this disease to increase year by year. Surgical operation is the main treatment. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Normal Pelvic Floor
- What is being tested?
- Dynamic Magnetic resonance imaging
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2021
- 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 30 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a study comparing 60 cases (POP) to 20 controls (Non POP,with normal pelvic floor support) defined by using Pelvic Organ Prolapse Quantification (POP-Q) exams.All recruits will undergo the MRI evaluation,and the basic information of them will be recorded.
Who may be able to join
- Female who were diagnosed with pelvic organ prolapse by using Pelvic Organ Prolapse Quantification (POP-Q) exams;
- Without history of pelvic surgery;
- Could cooperate smoothly with valsalva maneuver.
Who cannot join
- Combined with gynecologic malignant tumors；
- With MRI contraindications；
- Female who refuse to undergo MRI evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: The 3D Reconstruction Research of Pelvic Organ Prolapse Disease and the Establishment of Assessment for Space Coordinates
Female pelvic organ prolapse (FPOP) is one of the main diseases affecting the quality of life of middle aged and elderly women in non-neoplastic diseases. An aging population makes the incidence of this disease to increase year by year. Surgical operation is the main treatment. While the recurrence rate of classic repair surgery is high, the method of patch implantation reinforces the supporting force, which significantly reduce the recurrence rate. However, this method is costly and is associated with complications which may trigger new symptoms. As such, there is still no perfect surgical method. The main reason for this is that the assessment method of pelvic defects is crude and indirect, which results in the diagnosis of FPOP only representing external problems whereas, inner defected parts are not properly assessed. In recent years, research with the use of 2D and 3D MRI reconstructions on the anus levator muscle and ligament has become a hot topic. It found that the characteristic of the high resolution of soft tissue in the magnetic resonance imaging (MRI) has a big advantage in pelvic floor study.The investigators commenced the study of 3D reconstruction technology based on the MRI datasets in 2009. The investigators have mastered the most common, key technologies of MRI three-dimensional reconstruction. The investigators have done research targeted on the reconstruction methods of the normal pelvis, viscera, ligaments, pelvic floor muscles. This project is aimed at 3D reconstruction of the whole pelvic base on static and dynamic MRI images from FPOP patients, and establish the corresponding space coordinates assessment system to do location and quantitative research of the pelvic viscera and its support structure, thus providing a FPOP diagnosis platform that is more precise, direct and comprehensive.
- Conditions
- Pelvic Organ Prolapse, Normal Pelvic Floor
- Being tested
- Dynamic Magnetic resonance imaging
- Keywords
- pelvic organ prolapse, dynamic magnetic resonance imaging, three-dimensional reconstruction, space coordinates
- 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.
Dynamic Magnetic resonance imagingOther
| Study group | Role | What they receive |
|---|---|---|
| POP | Female patients with pelvic organ prolapse,such as: cystocele, uterine prolapse, the vault prolapse, rectal prolapse ,undergo pelvic floor reconstruction surgery.Before and after sugery,take dynamic magnetic resonance imaging scan. Receives: Other: Dynamic Magnetic resonance imaging | |
| Non-POP | Females with normal pelvic floor support,don't need pelvic floor reconstruction surgery,only take once dynamic magnetic resonance imaging scan. Receives: Other: Dynamic Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder，uterus and rectum space coordinates.
Measured: september 1,2017 to september 1,2019
levator ani muscle space coordinates.
Measured: september 1,2017 to september 1,2019
Secondary outcomes (3)
bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL line
Measured: september 1,2016 to september 1,2019
levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle.
Measured: september 1,2017 to september 1,2019
Urethral rotation Angle,posterior vesicourethral angle.
Measured: september 1,2017 to september 1,2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startSep 2016
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
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 Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146195
- Sponsor's protocol ID
- NFEC2013032-3
- Status last verified
- Sep 2016
- First submitted
- 28 Mar 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tang L, Liang S, Chen C, Feng J, Chen L, Peng C, Liu P. Comparison of urethral parameters in females presenting cystoceles with and without stress urinary incontinence based on dynamic magnetic resonance imaging: are they different? Abdom Radiol (NY). 2024 Aug;49(8):2902-2912. doi: 10.1007/s00261-023-04175-7. Epub 2024 Mar 18.
PubMed 38498153
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 3D Reconstruction Research of Pelvic Organ Prolapse Disease and the Establishment of Assessment for Space Coordinates
- ClinicalTrials.gov ID
- NCT03146195
- Acronym / sponsor ID
- NFEC2013032-3
- Conditions
- Pelvic Organ Prolapse, Normal Pelvic Floor
- Keywords
- pelvic organ prolapse, dynamic magnetic resonance imaging, three-dimensional reconstruction, space coordinates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 May 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.
Female pelvic organ prolapse (FPOP) is one of the main diseases affecting the quality of life of middle aged and elderly women in non-neoplastic diseases. An aging population makes the incidence of this disease to increase year by year. Surgical operation is the main treatment. While the recurrence rate of classic repair surgery is high, the method of patch implantation reinforces the supporting force, which significantly reduce the recurrence rate. However, this method is costly and is associated with complications which may trigger new symptoms. As such, there is still no perfect surgical method. The main reason for this is that the assessment method of pelvic defects is crude and indirect, which results in the diagnosis of FPOP only representing external problems whereas, inner defected parts are not properly assessed. In recent years, research with the use of 2D and 3D MRI reconstructions on the anus levator muscle and ligament has become a hot topic. It found that the characteristic of the high resolution of soft tissue in the magnetic resonance imaging (MRI) has a big advantage in pelvic floor study.The investigators commenced the study of 3D reconstruction technology based on the MRI datasets in 2009. The investigators have mastered the most common, key technologies of MRI three-dimensional reconstruction. The investigators have done research targeted on the reconstruction methods of the normal pelvis, viscera, ligaments, pelvic floor muscles. This project is aimed at 3D reconstruction of the whole pelvic base on static and dynamic MRI images from FPOP patients, and establish the corresponding space coordinates assessment system to do location and quantitative research of the pelvic viscera and its support structure, thus providing a FPOP diagnosis platform that is more precise, direct and comprehensive.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POP | – | Other: Dynamic Magnetic resonance imagingFemale patients with pelvic organ prolapse,such as: cystocele, uterine prolapse, the vault prolapse, rectal prolapse ,undergo pelvic floor reconstruction surgery.Before and after sugery,take dynamic magnetic resonance imaging scan. |
| Non-POP | – | Other: Dynamic Magnetic resonance imagingFemales with normal pelvic floor support,don't need pelvic floor reconstruction surgery,only take once dynamic magnetic resonance imaging scan. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a study comparing 60 cases (POP) to 20 controls (Non POP,with normal pelvic floor support) defined by using Pelvic Organ Prolapse Quantification (POP-Q) exams.All recruits will undergo the MRI evaluation,and the basic information of them will be recorded.
Key inclusion criteria (3 listed)
- Female who were diagnosed with pelvic organ prolapse by using Pelvic Organ Prolapse Quantification (POP-Q) exams;
- Without history of pelvic surgery;
- Could cooperate smoothly with valsalva maneuver.
Key exclusion criteria (3 listed)
- Combined with gynecologic malignant tumors；
- With MRI contraindications；
- Female who refuse to undergo MRI evaluation.
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 |
|---|---|---|
| Dynamic Magnetic resonance imaging | Other | Non-POP, POP |
Primary outcome
Bladder，uterus and rectum space coordinates.
Time frame: september 1,2017 to september 1,2019
levator ani muscle space coordinates.
Time frame: september 1,2017 to september 1,2019
3 secondary outcomes
bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL line
Time frame: september 1,2016 to september 1,2019
levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle.
Time frame: september 1,2017 to september 1,2019
Urethral rotation Angle,posterior vesicourethral angle.
Time frame: september 1,2017 to september 1,2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Derived from this study: PubMed 38498153Tang L, Liang S, Chen C, Feng J, Chen L, Peng C, Liu P. Comparison of urethral parameters in females presenting cystoceles with and without stress urinary incontinence based on dynamic magnetic resonance imaging: are they different? Abdom Radiol (NY). 2024 Aug;49(8):2902-2912. doi: 10.1007/s00261-023-04175-7. Epub 2024 Mar 18.
- Individual participant dataSharing planned: No
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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?
An observational study of Pelvic Organ Prolapse and Normal Pelvic Floor, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 3 inclusion and 3 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 9 May 2017. 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 China. 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 PING LIU, PHD (13725263091, lpivy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder，uterus and rectum space coordinates. (time frame: september 1,2017 to september 1,2019). The study lists 2 primary outcomes in all. 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 NCT03146195, 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 9 May 2017.