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

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

Study Overview

• Status: Completed
• Conditions: Urogenital Prolapse
• Intervention / Treatment: Procedure: sacrospinous ligament fixation; Procedure: 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

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Department of Ob & Gyn, Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sacrospinous ligament fixation group; The patients will receive sacrospinous ligament fixation operation.	Procedure: sacrospinous ligament fixation; The participants will receive sacrospinous ligament fixation.
Experimental: ischial spine fascia fixation group; The patients will receive ischial spine fascia fixation operation.	Procedure: ischial spine fascia fixation; The participants will receive ischial spine fascia fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective success	no prolapse, stage I or only asymptomatic stage II prolapse	3 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Floor Distress Inventory-20 (PFDI-20)	to evaluate the quality of life in 3 domains	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	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	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	through study completion, an average of 1 year
recurrence rate	more than asymptomatic stage II prolapse after 3 months	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	1 year after operation

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Chang Ren, M.D., Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
• Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
• Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.
• Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
• Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
• Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. doi: 10.1111/j.1471-0528.1988.tb06486.x.
• Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. doi: 10.1016/S0029-7844(96)00337-7.
• Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003 Jan;188(1):108-15. doi: 10.1067/mob.2003.101.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimated): December 29, 2016

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Clinical outcome; Pelvic organ prolapse; Sacrospinous ligament fixation; Ischial spine fascia fixation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse
• Other Study ID Numbers: RC-H0407-8160061244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO