Urogenital Prolapse Clinical Trial
Official title:
A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04980196 -
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| Recruiting |
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N/A | |
| Completed |
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Phase 4 |