A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
The participants will receive ischial spine fascia fixation.
The participants will receive sacrospinous ligament fixation.
Department of Ob & Gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
objective success
no prolapse, stage I or only asymptomatic stage II prolapse
Time frame: 3 months after operation
Pelvic Floor Distress Inventory-20 (PFDI-20)
to evaluate the quality of life in 3 domains
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
recurrence rate
more than asymptomatic stage II prolapse after 3 months
Time frame: 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
Time frame: 1 year after operation
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