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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Device: Gynecare Prolift Mesh; Procedure: Traditional Surgery; Device: Perigee and Apogee Mesh

• Registration Number: NCT03070873
• Lead Sponsor: Nanjing Medical University

Brief 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。

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2014-01-30
• Study Completion: 2014-01-30
• Status Verified: 2017-02
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-28
• Last Update Submitted: 2017-02-28
• Study First Posted: 2017-03-06
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 258

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	Gynecare Prolift Mesh	accepted Gynecare prolift mesh
group C	Traditional Surgery	Traditional surgery without any mesh
group A	Perigee and Apogee Mesh	accepted Perigee and Apogee mesh(PA)

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse Quantification	at 24 months after surgery	the prolapse of stage II and above is defined as recurrence in POP-Q stage.
mesh exposure	at 24 months after surgery	mesh was seen in the vagina by gynecological examination
sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire	baseline	PISQ-12
pelvic floor distress inventory short form	baseline	PFDI-20

Secondary Outcome Measures

Name	Time	Method
Number of constipation	1 months after surgery
Day of postoperative indwelling catheter	1 months after surgery
Volume of bleeding	during the operation
Elevated blood pressure	during the operation
stress urinary incontinence	3 months after surgery	leakage of urine with exertion or with sneezing or coughing