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

Nanjing Medical University

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: Gynecare Prolift Mesh; Procedure: Traditional Surgery; Device: Perigee and Apogee Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03070873

NMU-201666

Details and patient eligibility

About

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.

Full 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。

Enrollment: 258 patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with stage III ~ IV degree of anterior and posterior vaginal wall prolapse and uterine prolapse (total pelvic floor prolapse) by the Pelvic Organ Prolapse Quantification System (POP-Q) were included

Exclusion criteria

• Simple anterior or posterior wall prolapse, simple uterine prolapse, combined with stress urinary incontinence, overactive bladder (OAB), pelvic floor repair surgery history and recurrent patients
• Local or systemic conditions that would preclude surgery or affect healing such as restricted leg motion (inability to conform to the lithotomy position)
• Vaginal bleeding;coagulation disorders
• Infection,or uncontrolled hypertension and diabetes mellitus
• Pelvic cancer and radiation to the pelvic area in the previous 6 months.
• Also women of reproductive age, and planning of pregnancy were also excluded for mesh usage.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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258 participants in 3 patient groups, including a placebo group

group A

Experimental group

Description:

accepted Perigee and Apogee mesh(PA)

Treatment:

Device: Perigee and Apogee Mesh

group B

Experimental group

Description:

accepted Gynecare prolift mesh

Treatment:

Device: Gynecare Prolift Mesh

group C

Placebo Comparator group

Description:

Traditional surgery without any mesh

Treatment:

Procedure: Traditional Surgery