RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients

Sacrospinous Ligament Fixation vs. Ischial Spine Fasicia Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center, Prospective, Randomized Clinical Trial

This trial is designed to investigate the efficacy and safety of two native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients (POP-Q II-IV) and compare the outcome in prolapse women randomized to Sacrospinous ligament fixation (SSLF) and Ischial spinous fascia fixation (ISFF).

Study Overview

• Status: Recruiting
• Conditions: Apical Prolapse
• Intervention / Treatment: Procedure: native tissue repair procedures with conventional surgical instruments

Detailed Description

The population will include Chinese female patients with advanced apical prolapse (stage II-III) and who are undergoing Sacrospinous Ligament Fixation (SSLF) and Ischial spinous fascia fixation (ISFF) procedure using conventional surgical instruments without special instrument. After enrollment, standardized baseline data including demographics, POPQ evaluation, series of validated questionaires via interviews( PFDI-20, PFIQ-7, PISQ-12) will be collected by study personnel at the baseline visit. Eligible consenting patients will proceed to randomizations with equal probability of assignment to SSLF or ISFF. Randomization to either SSLF or ISFF will take place preoperatively by each clinical site using a random permutated block design. After index surgical intervention, scheduled follow-up will occur at 3, 6, 12, 24 and 36 months after the index surgery. At the follow-up visits, POPQ examination will be performed and an update of current medications, an assessment of new or continuing pelvic floor disorders, adverse events that occurred since the previous evaluation, and an assessment of health care costs. A series of validated instruments will be administered via interviews to including PFDI-20, PFIQ-7, PISQ-12, PGI-C.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuxin Dai, MD; Phone Number: 0086-010-69156204; Email: helen81918@163.com
• Study Contact Backup: Name: Lan Zhu, MD

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230041
      • Recruiting
      • 2nd Affiliated hospital of Anhui Medical college
      • Contact: Wenyan Wang
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yuxin Dai, MD; Phone Number: 0086-010-69156204; Email: helen81918@163.com
      • Contact: Lan Zhu
    • Beijing, Beijing, China, 100037
      • Recruiting
      • 1st Affiliated hospital of PLA general hospital
      • Contact: Yongxian Lu
  • Jiangsu
    • Suzhou, Jiangsu, China, 215008
      • Recruiting
      • Suzhou City Hospital
      • Contact: Shunyu Hou
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Shanghai first maternity and infant hospital
      • Contact: Zhiyuan Dai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV)
2. SSLF or ISFF is proceeded as described before，while ancillary procedures like vaginal hysterectomy, anterior/posterior vaginal wall repair without mesh or mid-urethral suspension could be performed simultaneously.
3. Women who have been eligible for long-term follow-up.
4. Women who agreed to participate in the study and signed informed consent.

Exclusion Criteria:

1. Women who have surgical history for prolapse with mesh.
2. Women who have contraindication for surgical procedure
3. Women who are unable to comply with the study procedures

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: SSLF-CSI; native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Sacrospinous ligament fixation (SSLF) .	Procedure: native tissue repair procedures with conventional surgical instruments; Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).
Active Comparator: ISFF-CSI; native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Ischial spinous fascia fixation (ISFF)	Procedure: native tissue repair procedures with conventional surgical instruments; Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of surgical success	definition for surgical success is symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire. There is no need of further treatment for prolapse, such as reoperation or pessary.	up to 36 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of Postoperative recurrence	definition for postoperative recurrence is symptomatic prolapse above grade II occurred 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. Vaginal swelling sensation, that is answer "yes" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". There is need of further treatment for prolapse, such as reoperation or pessary.	from 3 months after operation up to 36 months after operation
visual analogue scales	postoperative pain evaluation esp. hip pain by visual analogue scales (VAS). Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 10 centimeter line with a statement at each end representing one extreme of the dimension being measured (most often intensity of pain). VAS result will be reported ranging from 0 to 10, with 0 representing no pain, and 10 representing unbearable severe pain	up to 36 months after operation, usuallly within 3 days after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7)	Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.	up to 36 months after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20)	Relief of symptoms using validated instruments, pelvic floor distress inventory short form 20(PFDI-20), PFDI-20 scores 0-300, the higher the severer negative influence on patient.	up to 36 months after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12)	Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.	up to 36 months after operation
results of postoperative symptomatic improvement using patient global impression of change (PGI-C)	Relief of symptoms using patient global impression of change (PGI-C)， PGI-C scores 1-7, the higher, the the severer negative influence on patient.	up to 36 months after operation
intraoperative and post operative complications	using IUGA/ICS joint terminology CTS coding system and dingo system	up to 36 months after operation

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yongxian Lu, 1st Affiliated hospital of PLA general hospital; Principal Investigator: Zhiyuan Dai, Shanghai first maternity and infant hospital; Principal Investigator: Wenyan Wang, 2nd Affiliated hospital of Anhui Medical college; Principal Investigator: Zhaoai Li, Shan'xi Province Women's and Children's Hospital; Principal Investigator: Yuling Wang, Foshan Women's and Children's Hospital; Principal Investigator: Shunyu Hou, Suzhou City Hospital; Principal Investigator: Xiangjuan Li, Hangzhou Women's and Children's Hospital; Principal Investigator: Lubin Liu, Chongqing Women's and Children's Hospital; Principal Investigator: Le Ma, Beijing Obstetrics and Gynecology Hospital; Principal Investigator: Tao Xu, Statistics Department of Peking Union Medical College; Principal Investigator: Joseph Schaffer, UT Southwestern Medical Center; Principal Investigator: Marko J Jachtorowycz, Saint Francis Memorial Hospital; Study Chair: Lan Zhu, Peking Union Medical College Hospital; Study Director: Yuxin Dai, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.
• 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.
• Ren C, Song XC, Zhu L, Ai FF, Shi HH, Sun ZJ, Chen J, Lang JH. [Prospective cohort study on the outcomes of sacrospinous ligament fixation using conventional instruments in treating stage Ⅲ-Ⅳ pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25;52(6):369-373. doi: 10.3760/cma.j.issn.0529-567X.2017.06.003. Chinese.
• Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. Am J Obstet Gynecol. 2015 Jun;212(6):755.e1-755.e27. doi: 10.1016/j.ajog.2015.02.017. Epub 2015 Feb 25.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: PekingUMCH SSLFvsISFF-CSI

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No