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The 3D Reconstruction Research of Pelvic Organ Prolapse Disease

The 3D Reconstruction Research of Pelvic Organ Prolapse Disease and the Establishment of Assessment for Space Coordinates

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03146195
Enrollment
80
Registered
2017-05-09
Start date
2016-09-30
Completion date
2021-12-31
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pelvic Floor, Pelvic Organ Prolapse

Keywords

pelvic organ prolapse, dynamic magnetic resonance imaging, three-dimensional reconstruction, space coordinates

Brief 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. 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.

Interventions

OTHERDynamic Magnetic resonance imaging

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Female who were diagnosed with pelvic organ prolapse by using Pelvic Organ Prolapse Quantification (POP-Q) exams; 2. Without history of pelvic surgery; 3. Could cooperate smoothly with valsalva maneuver.

Exclusion criteria

1. Combined with gynecologic malignant tumors; 2. With MRI contraindications; 3. Female who refuse to undergo MRI evaluation.

Design outcomes

Primary

MeasureTime frame
Bladder,uterus and rectum space coordinates.september 1,2017 to september 1,2019
levator ani muscle space coordinates.september 1,2017 to september 1,2019

Secondary

MeasureTime frame
bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL lineseptember 1,2016 to september 1,2019
levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle.september 1,2017 to september 1,2019
Urethral rotation Angle,posterior vesicourethral angle.september 1,2017 to september 1,2019

Countries

China

Contacts

Primary ContactPING LIU, PHD
lpivy@126.com13725263091
Backup ContactChunLin CHEN, PHD
jieru@163.com13725263051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026