The 3D Reconstruction Research of Pelvic Organ Prolapse Disease

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03146195
• Other study ID #: NFEC2013032-3
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2017
• Last updated: May 5, 2017
• Start date: September 2016
• Est. completion date: December 2021

Study information

• Verified date: September 2016
• Source: Nanfang Hospital of Southern Medical University
• Contact: PING LIU, PHD
• Phone: 13725263091
• Email: lpivy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Normal Pelvic Floor
• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Dynamic Magnetic resonance imaging

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder,uterus and rectum space coordinates.		september 1,2017 to september 1,2019
Primary	levator ani muscle space coordinates.		september 1,2017 to september 1,2019
Secondary	bladder neck, internal cervix, external cervix, anorectal junction's distance from the PCL line		september 1,2016 to september 1,2019
Secondary	levator hiatus width and length, Levator symphasis gap leftside and rightside,levator plate angle.		september 1,2017 to september 1,2019
Secondary	Urethral rotation Angle,posterior vesicourethral angle.		september 1,2017 to september 1,2019