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

Study Overview
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Brief Summary
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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
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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。

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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Perigee and Apogee Mesh
* Device: Gynecare Prolift Mesh
* Procedure: Traditional Surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>accepted Perigee and Apogee mesh(PA) | Device: Perigee and Apogee Mesh<br>* 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.<br>|
| Experimental: group B<br>accepted Gynecare prolift mesh | Device: Gynecare Prolift Mesh<br>* 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.<br>|
| Placebo Comparator: group C<br>Traditional surgery without any mesh | Procedure: Traditional Surgery<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Vaginal mesh, Mesh complications