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The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.
Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20，ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extraperitoneal high sacral ligament suspension Group | Experimental | We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them. |
|
| Sacrospinous Ligament Suspension Group | Active Comparator | We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extraperitoneal high sacral ligament suspension surgery | Procedure | The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments . |
| Measure | Description | Time Frame |
|---|---|---|
| changes in POP-Q score at different time nodes | Gynecological examination | pre-operation and post-operation(at 1month, 3 month, 6 month and a year) |
| Measure | Description | Time Frame |
|---|---|---|
| UDI-6 scores at different time nodes UDI-6 | Questionnaires on lower urinary tract symptoms and quality of life | pre-operation and post-operation(at 1month, 3 month, 6 month and a year) |
| Postoperative urinary incontinence assessment |
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Inclusion Criteria:
Age ≥30 years old;
pelvic organ prolapse, with or without abnormal urination or defecation or sexual disturbance, which affects the quality of life
Pelvic organ prolapse quantitation (POP-Q) is greater than or equal to Those who are in stage II and have symptoms and require surgery
The patient agrees to conduct the study and can be followed up on time.
Exclusion Criteria:
Those who cannot tolerate surgery and anesthesia
Those who need to remove the uterus
Those who have removed the uterus
Those who cannot be followed up on time.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiuli sun, professor | Contact | 010-88324354 | sunxiuli03351@126.com |
| Name | Affiliation | Role |
|---|---|---|
| xiuli sun, professor | Beijing Key Laboratory of Female Pelvic Floor Disorders | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
Extraperitoneal high uterosacral ligament sling is effective in treating pelvic organ prolapse, and postoperative anatomical recovery is good, not inferior to traditional sacral ligament sling
2 years
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| Sacrospinous ligament fixation | Procedure | The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments. |
|
One hour pad test
| post-operation(at 1month, 3 month, 6 month and a year) |
| OABss score at different time nodes | Questionnaires lower urinary tract symptoms | post-operation(at 1month, 3 month, 6 month and a year) |
| PFDI-20 score at different time nodes | Questionnaires on pelvic floor function and lower urinary tract symptoms and quality of life | post-operation(at 1month, 3 month, 6 month and a year) |
| ICIQ-SF score at different time nodes | Questionnaires on lower urinary tract symptoms | post-operation(at 1month, 3 month, 6 month and a year) |
| I-QoL score at different time nodes | Questionnaires on lower urinary tract symptoms and quality of life | post-operation(at 1month, 3 month, 6 month and a year) |
| PISQ-12 score at different time nodes | Questionnaires on pelvic floor function and lower urinary tract symptoms and sexual quality of life | post-operation(at 1month, 3 month, 6 month and a year) |
| PFIQ-7 score at different time nodes | Questionnaires on pelvic floor function and quality of life | post-operation(at 1month, 3 month, 6 month and a year) |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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