Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation
- Conditions
- Urogenital Prolapse
- Interventions
- Procedure: ischial spine fascia fixationProcedure: sacrospinous ligament fixation
- Registration Number
- NCT03005613
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ischial spine fascia fixation group ischial spine fascia fixation The patients will receive ischial spine fascia fixation operation. sacrospinous ligament fixation group sacrospinous ligament fixation The patients will receive sacrospinous ligament fixation operation.
- Primary Outcome Measures
Name Time Method objective success 3 months after operation no prolapse, stage I or only asymptomatic stage II prolapse
- Secondary Outcome Measures
Name Time Method Pelvic Floor Distress Inventory-20 (PFDI-20) Change from Baseline in PFDI-20 at 3 months and 1 year to evaluate the quality of life in 3 domains
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) Change from Baseline in PISQ-12 at 3 months and 1 year to evaluate the sexual function
complications through study completion, an average of 1 year peri-operative:massive bleeding, organ injury; post-operative: pelvic hematoma, pain, de novo UI, de novo dyspareunia
subjective satisfaction ( according to a scale of 5 degrees: significantly worse, worse, no change, improved, greatly improved) 1 year after operation Patient's response as improved or greatly improved
Pelvic Floor Impact Questionnaire-7 (PFIQ-7) Change from Baseline in PFIQ-7 at 3 months and 1 year to evaluate the quality of life in 3 domains
recurrence rate 3 months after operation more than asymptomatic stage II prolapse after 3 months
Trial Locations
- Locations (1)
Department of Ob & Gyn, Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China