Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation

Study Overview
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Brief Summary
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A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

Detailed Description
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Investigational intervention：SSLF or ISFF operations Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation. Principal Investigator：Chang Ren, M.D., Department of Obstetrics & Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. Study subjects：Adult patients with symptomatic stage II IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion. Study objectives：The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II  IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life. Study design：Prospective, Single-Blind, Randomized, Clinical Trial Intervention： ISFF group：Patients receive ISFF according to randomization. SSLF group：Patients receive SSLF according to randomization Sample size：76 patients (38 in ISFF group, 38 in SSLF group) Primary endpoint: •objective success rates at 3 months after operations. Secondary endpoints: peri-operative parameters . subjective satisfactory rates at 1 year after operations quality of life questionnaires at 1 year after operations Safety endpoints: complications

Official Title
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A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation

Conditions
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Urogenital Prolapse

Intervention / Treatment
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* Procedure: ischial spine fascia fixation
* Procedure: sacrospinous ligament fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age≤65 years, for those scheduled to receive hysterectomy age≥40 years patients with symptomatic stage II IV uterine or vaginal vault prolapse receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital Exclusion Criteria: plans to live abroad within follow-up span contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations patients with hip joint problem who could not pose a lithotomy position

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sacrospinous ligament fixation group<br>The patients will receive sacrospinous ligament fixation operation. | Procedure: sacrospinous ligament fixation<br>* The participants will receive sacrospinous ligament fixation.<br>|
| Experimental: ischial spine fascia fixation group<br>The patients will receive ischial spine fascia fixation operation. | Procedure: ischial spine fascia fixation<br>* The participants will receive ischial spine fascia fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective success | no prolapse, stage I or only asymptomatic stage II prolapse | 3 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Floor Distress Inventory-20 (PFDI-20) | to evaluate the quality of life in 3 domains | Change from Baseline in PFDI-20 at 3 months and 1 year | 
| Pelvic Floor Impact Questionnaire-7 (PFIQ-7) | to evaluate the quality of life in 3 domains | Change from Baseline in PFIQ-7 at 3 months and 1 year | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) | to evaluate the sexual function | Change from Baseline in PISQ-12 at 3 months and 1 year | 
| complications | peri-operative:massive bleeding, organ injury; post-operative: pelvic hematoma, pain, de novo UI, de novo dyspareunia | through study completion, an average of 1 year | 
| recurrence rate | more than asymptomatic stage II prolapse after 3 months | 3 months after operation | 
| subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved) | Patient's response as improved or greatly improved | 1 year after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic organ prolapse, Sacrospinous ligament fixation, Ischial spine fascia fixation, Clinical outcome