Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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。
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | accepted Perigee and Apogee mesh(PA) |
|
| group B | Experimental | accepted Gynecare prolift mesh |
|
| group C | Placebo Comparator | Traditional surgery without any mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perigee and Apogee Mesh | Device | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yu-Fei Shen | director of Gynecology Department , Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
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.
| Gynecare Prolift Mesh | Device | 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. |
|
| Traditional Surgery | Procedure | 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. |
|
| 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 |
| 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 |