the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Procedure: Sacrospinous ligament fixationProcedure: Extraperitoneal high sacral ligament suspension surgery
- Registration Number
- NCT05189665
- Lead Sponsor
- Peking University People's Hospital
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 124
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sacrospinous Ligament Suspension Group Sacrospinous ligament fixation We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them. Extraperitoneal high sacral ligament suspension Group Extraperitoneal high sacral ligament suspension surgery We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
ICIQ-SF score at different time nodes post-operation(at 1month, 3 month, 6 month and a year) Questionnaires on lower urinary tract symptoms
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
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
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
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
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
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China