NCT03070873

Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery, and also studied the influence of some surgical procedures on the prognosis.

Detailed description

Pelvic organ prolapse is defined as a downward descent of the pelvic organs that results in the protrusion of vagina, uterus, or both. The investigators designed a prospective study in this article to evaluate the efficacy, the life quality and the complications of two different meshes of type I (one is Perigee/Apogee, the other is named Gynecare prolift) versus traditional surgery. The investigators also studied the influence of some surgical procedures on the prognosis. In this study，The investigators divided the patients randomly into three groups :the group A was a total of 91 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction combined Perigee and Apogee polypropylene mesh(PA)；the group B was a total of 97 patients who accepted transvaginal hysterectomy and total pelvic floor reconstruction with Gynecare prolift polypropylene mesh；the group C was a total of 70 patients who accepted transvaginal hysterectomy and anterior and posterior vaginal wall repair without any mesh.The investigators did POP-Q measurements and questionnaire preoperatively and postoperatively and recorded volume of bleeding，day of postoperative indwelling catheter and the mesh complications。

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	Perigee and Apogee Mesh	The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
DEVICE	Gynecare Prolift Mesh	The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
PROCEDURE	Traditional Surgery	The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-01-30
• Completion: 2014-01-30
• First posted: 2017-03-06
• Last updated: 2017-03-06

Regulatory

• FDA-regulated device study