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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Apical Prolapse

Intervention / Treatment
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* Procedure: native tissue repair procedures with conventional surgical instruments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV) 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. Women who have been eligible for long-term follow-up. Women who agreed to participate in the study and signed informed consent. Exclusion Criteria: Women who have surgical history for prolapse with mesh. Women who have contraindication for surgical procedure Women who are unable to comply with the study procedures
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SSLF-CSI<br>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<br>* 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).<br>|
| Active Comparator: ISFF-CSI<br>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<br>* 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).<br>|

What is the study measuring?
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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 |