Anatomical and Functional Outcomes of Perigee and Apogee Mesh in Total Pelvic Floor Reconstruction Versus Gynecare Prolift
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 258
- Primary Endpoint
- Pelvic Organ Prolapse Quantification
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Double (Participant, Investigator)
Masking Description
In the study the operation was performed by three surgeons, the patients received surgery by the doctor when the patients saw in the outpatient clinic.
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Pelvic Organ Prolapse Quantification
Time Frame: at 24 months after surgery
the prolapse of stage II and above is defined as recurrence in POP-Q stage.
mesh exposure
Time Frame: 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
Time Frame: baseline
PISQ-12
pelvic floor distress inventory short form
Time Frame: baseline
PFDI-20
Secondary Outcomes
- Number of constipation(1 months after surgery)
- Volume of bleeding(during the operation)
- Day of postoperative indwelling catheter(1 months after surgery)
- Elevated blood pressure(during the operation)
- stress urinary incontinence(3 months after surgery)
Investigators
Xirong Guo
Vice president of Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
Nanjing Medical University