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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Perigee and Apogee Mesh; Device: Gynecare Prolift Mesh; Procedure: Traditional Surgery

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 Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; accepted Perigee and Apogee mesh(PA)	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.
Experimental: group B; accepted Gynecare prolift 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.
Placebo Comparator: group C; Traditional surgery 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Study Director: Yu-Fei Shen, director of Gynecology Department , Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): January 30, 2014
• Study Completion (Actual): January 30, 2014

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Quality of life; Vaginal mesh; Mesh complications
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: NMU-201666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes