NCT03005613

Sacrospinous Ligament Fixation vs 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Urogenital Prolapse

Interventions

Type	Name	Description
PROCEDURE	ischial spine fascia fixation	The participants will receive ischial spine fascia fixation.
PROCEDURE	sacrospinous ligament fixation	The participants will receive sacrospinous ligament fixation.

Timeline

• Start date: 2017-01-15
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2016-12-29
• Last updated: 2026-01-16

Locations

1 site across 1 country: China