Clinical trial NCT03070873: Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
Official title: Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Quality of life
Vaginal mesh
Mesh complications
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 258
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

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。

Eligibility criteria: 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.

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification
timeFrame: at 12 months after surgery
measure: sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
timeFrame: at 12 months after surgery
measure: pelvic floor distress inventory short form
timeFrame: at 12 months after surgery
measure: mesh exposure
timeFrame: at 12 months after surgery
measure: sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
timeFrame: at 24 months after surgery
measure: Pelvic Organ Prolapse Quantification
timeFrame: at 24 months after surgery
measure: pelvic floor distress inventory short form
timeFrame: at 24 months after surgery
measure: mesh exposure
timeFrame: at 24 months after surgery
measure: sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire
timeFrame: baseline
measure: pelvic floor distress inventory short form
timeFrame: baseline
Secondary outcomes:
measure: stress urinary incontinence
timeFrame: at 1 months after surgery
measure: stress urinary incontinence
timeFrame: 3 months after surgery
measure: Volume of bleeding
timeFrame: during the operation
measure: Elevated blood pressure
timeFrame: during the operation
measure: Day of postoperative indwelling catheter
timeFrame: 1 months after surgery
measure: Number of constipation
timeFrame: 1 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: director of Gynecology Department , Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
name: Yu-Fei Shen
role: STUDY_DIRECTOR
References: