Ischia Spinous Fascia Fixation Procedure Versus Modified Total Pelvic Floor Reconstructive Surgery for Pelvic Organ Prolapse Stage III

• •Anatomical improvement according to POP-Q score. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  
• •Anatomical improvement according to POP-Q score. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  
• •Anatomical improvement according to POP-Q score. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  
• •Anatomical improvement according to POP-Q score. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  

• •Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery. [ Time Frame: At discharge, an expected average of 5 days after operation. ] [ Designated as safety issue: Yes ]
  
• •Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 24 hours post surgery and at the 6-week visit ] [ Designated as safety issue: Yes ]
  
• •Presence/absence of complications (composite score). [ Time Frame: Up to 6 weeks. ] [ Designated as safety issue: Yes ]
  The occurrence (in the per-operative phase or within 6 weeks post-op) of at least one of the following: 1) bleeding complications; 2) infectious complications; 3) any wound caused by a surgeon movement: bladder, ureteral, or vascular injuries; 4)medical complications: deep vein thrombosis, pulmonary embolism and etc.Complications will be categorized using the Dindo surgical complication grading scale.
  
  
• •Change from baseline in PFIQ-7 scores. [ Time Frame: 1 year, 2 years and 3 years. ] [ Designated as safety issue: No ]
  
• •In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline) [ Time Frame: 1 year, 2 years and 3 years. ] [ Designated as safety issue: No ]
  
• •Subject global impression assessed on a 5 point Likert scale [ Time Frame: 1 year, 2 years and 3 years. ] [ Designated as safety issue: No ]
  
• •Presence/absence of complications (composite score) [ Time Frame: Up to 3 years. ] [ Designated as safety issue: Yes ]
  Long-term negative outcomes of the surgical procedure will also be recorded until 3 years after surgery. For example, mesh erosion, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.
  
  

Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.

Vaginal procedures used for restoring the vaginal apex support include Ischia spinous fascia fixation procedure with native tissue and modified total pelvic floor reconstructive surgery with mesh. They are both developed and popular in China. Clinical practice showed that they were both safe, efficient and cost-effective. Recurrent rates of both procedures after 1 year follow-up were about 10%, and quality of life improved significantly from the baseline, while the.complications are different.

The purpose of this multicenter, prospective, and comparative study is to evaluate the effectiveness and safety of these two procedures in the treatment of symptomatic pelvic organ prolapse Stage III in China.