Pelvic Organ Prolapse
Conditions
Keywords
Quality of life, Vaginal mesh, Mesh complications
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。
Interventions
DEVICEPerigee 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.
DEVICEGynecare 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.
PROCEDURETraditional 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.
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Quantification | at 12 months after surgery | the prolapse of stage II and above is defined as recurrence in POP-Q stage. |
| sexual quality of life through the pelvic organ prolapse / urinary incontinence sexual questionnaire | at 12 months after surgery | PISQ-12 |
| pelvic floor distress inventory short form | at 12 months after surgery | PFDI-20 |
| mesh exposure | at 12 months after surgery | mesh was seen in the vagina by gynecological examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Day of postoperative indwelling catheter | 1 months after surgery | — |
| Volume of bleeding | during the operation | — |
| Number of constipation | 1 months after surgery | — |
| Elevated blood pressure | during the operation | — |
| stress urinary incontinence | at 1 months after surgery | leakage of urine with exertion or with sneezing or coughing |
Outcome results
None listed