Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse

• Anatomical improvement according to POP-Q score. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  
• Anatomical improvement according to POP-Q score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Anatomical improvement according to POP-Q score. [ Time Frame: 12 months ] [ 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 after surgery and postoperation visit at the 3-4 weeks. ] [ Designated as safety issue: Yes ]
  
• Discomfort of balloon removal, measured using VAS at time of removal. [ Time Frame: 24 hours after surgery. ] [ Designated as safety issue: Yes ]
  
• Subject discomfort of VSD by VAS. [ Time Frame: postoperation visit at 3-4 weeks. ] [ 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: 6 months, 12 months, 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: 6 months, 12 months, 2 years and 3 years. ] [ Designated as safety issue: No ]
  
• Subject global impression assessed on a 5 point Likert scale. [ Time Frame: 6 months, 12 months, 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.
  
  

The GYNECARE PROSIMA* system is a new technique and now available in China. It provides a simplified unanchored mesh repair, making surgery much simpler to perform and reduces the risk of the specific complications that may occur when tunneling devices beyond the pelvic cavity.

In clinical practice, many women have symptomatic prolapse, which requires surgical correction. They are relatively young, and therefore care more about the long-term outcomes and quality of life after procedure. The purpose of this multicenter and prospective study is to evaluate the effectiveness and safety of the GYNECARE PROSIMA* system in the treatment of symptomatic POP-Q Stage II-III pelvic organ prolapse.