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Pelvic organ prolapse(POP) is a common health problem and has significant negative effects on woman's quality of life. Transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our preliminary trial showed that the use of self-tailored mesh had good success rate (91.8% at 1-year follow-up) and low complication rate. The trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective .
The trial is a randomized controlled multi-center non-inferiority trial. The primary outcome measure is success rate at 1-year follow-up. The second outcomes are subjective improvement of quality of life, complications and costs. Analysis will be performed according to the intention to treat principle. Based on comparable success rate of 92% and 10% as the margin(beta 0.2 and one sided alpha 0.025), about 524 patients in total from 15 centers will be recruited per group including 10% drop-out. The aims of the research are to demonstrate whether self-tailored mesh is non-inferior to the mesh-kit. The finding of this research might influence the treatment selection for POP in China.
Pelvic Organ Prolapse
pelvic floor reconstructive surgery
The First Affiliated Hospital of Guangzhou Medical College
Peking Union Medical College Hospital
Published on BioPortfolio: 2017-09-15T00:23:21-0400
This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse. The goal of the study is to evaluate the change in pelvic ...
Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types of s...
The purpose of this study is to investigate the feasibility of undertaking a multi-centre randomised controlled trial of the effectiveness of a pelvic floor muscle training (PFMT) interven...
The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP. (*T...
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mes...
The aim of this study was to investigate knowledge and demographic factors associated with a lack of knowledge proficiency about urinary incontinence (UI) and pelvic organ prolapse (POP) among pregnan...
The symptoms of constipation and obstructed defecation are common in women with pelvic floor disorders. Female pelvic medicine and reconstructive surgery specialists evaluate and treat women with thes...
Although the effectiveness of pelvic floor muscle training in women with prolapse has been demonstrated in several studies, there seem to be subgroups of responders and nonresponders.
The objective of this study was to elicit information priorities from women considering treatment for pelvic organ prolapse (POP).
Pelvic organ prolapse is a medical condition that can cause pelvic discomfort as well as urinary and bowel complications. Approximately 25% of women in the United States and roughly 50% of women wo...
Injury, weakening, or PROLAPSE of the pelvic muscles, surrounding connective tissues or ligaments (PELVIC FLOOR).
Soft tissue formed mainly by the pelvic diaphragm, which is composed of the two levator ani and two coccygeus muscles. The pelvic diaphragm lies just below the pelvic aperture (outlet) and separates the pelvic cavity from the PERINEUM. It extends between the PUBIC BONE anteriorly and the COCCYX posteriorly.
Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.
Endoscopic examination, therapy or surgery of the female pelvic viscera by means of an endoscope introduced into the pelvic cavity through the posterior vaginal fornix.
The part of the pelvis, inferior to the pelvic brim, that comprises both the pelvic cavity and the part of the PERINEUM lying inferior to the PELVIC DIAPHRAGM.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...