Pelvic Organ Prolapse
Conditions
Keywords
Extraperitoneal high uterosacral ligament suspension
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREExtraperitoneal high sacral ligament suspension surgery
The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .
PROCEDURESacrospinous ligament fixation
The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in POP-Q score at different time nodes | pre-operation and post-operation(at 1month, 3 month, 6 month and a year) | Gynecological examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative urinary incontinence assessment | post-operation(at 1month, 3 month, 6 month and a year) | One hour pad test |
| OABss score at different time nodes | post-operation(at 1month, 3 month, 6 month and a year) | Questionnaires lower urinary tract symptoms |
| PFDI-20 score at different time nodes | post-operation(at 1month, 3 month, 6 month and a year) | Questionnaires on pelvic floor function and lower urinary tract symptoms and quality of life |
| UDI-6 scores at different time nodes UDI-6 | pre-operation and post-operation(at 1month, 3 month, 6 month and a year) | Questionnaires on lower urinary tract symptoms and quality of life |
| I-QoL score at different time nodes | post-operation(at 1month, 3 month, 6 month and a year) | Questionnaires on lower urinary tract symptoms and quality of life |
| PISQ-12 score at different time nodes | post-operation(at 1month, 3 month, 6 month and a year) | Questionnaires on pelvic floor function and lower urinary tract symptoms and sexual quality of life |
| PFIQ-7 score at different time nodes | post-operation(at 1month, 3 month, 6 month and a year) | Questionnaires on pelvic floor function and quality of life |
| ICIQ-SF score at different time nodes | post-operation(at 1month, 3 month, 6 month and a year) | Questionnaires on lower urinary tract symptoms |
Countries
China
Contacts
Primary Contactxiuli sun, professor
Outcome results
None listed