the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Randomized Controlled Study on the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Extraperitoneal high sacral ligament suspension surgery
* Procedure: Sacrospinous ligament fixation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extraperitoneal high sacral ligament suspension Group<br>We will recruit 62 POP patients ,and perform Surgery Extraperitoneal high sacral ligament suspension surgery on them. | Procedure: Extraperitoneal high sacral ligament suspension surgery<br>* The extraperitoneal high sacral ligament suspension surgery is to shorten the bilateral uterosacral ligaments .<br>|
| Active Comparator: Sacrospinous Ligament Suspension Group<br>We will recruit 62 POP patients ,and perform sacrospinous ligament suspension surgery on them. | Procedure: Sacrospinous ligament fixation<br>* The sacrospinous ligament fixation surgery is to open the front and back peritoneum through the vagina and shorten the bilateral uterosacral ligaments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extraperitoneal high uterosacral ligament suspension