Urogenital Prolapse
Conditions
Keywords
Pelvic organ prolapse, Sacrospinous ligament fixation, Ischial spine fascia fixation, Clinical outcome
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
Interventions
PROCEDUREischial spine fascia fixation
The participants will receive ischial spine fascia fixation.
PROCEDUREsacrospinous ligament fixation
The participants will receive sacrospinous ligament fixation.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective success | 3 months after operation | no prolapse, stage I or only asymptomatic stage II prolapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| recurrence rate | 3 months after operation | more than asymptomatic stage II prolapse after 3 months |
| 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORChang Ren, M.D.
Peking Union Medical College Hospital
Outcome results
None listed