GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

• Success based on overall POP-Q score at 24 months post-procedure. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP
• Success based on treated compartment ICS POP-Q stage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
• Success based on treated compartment ICS POP-Q stage [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
• Success defined as the leading edge within the hymen [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)
• Success defined as the leading edge within the hymen [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)
• Mean PFDI-20 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Mean PFDI-20 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Mean change from baseline in PFDI-20 scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Mean change from baseline in PFDI-20 scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Mean POPDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  POPDI is a sub score of PFDI-20
• Mean POPDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  POPDI is a sub score of PFDI-20
• Mean change from baseline in POPDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  POPDI is a sub scores of PFDI-20
• Mean change from baseline in POPDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  POPDI is a sub score of PFDI-20
• Mean CRADI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  CRADI is a sub score of PFDI-20
• Mean CRADI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  CRADI is a sub score of PFDI-20
• Mean change from baseline in CRADI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  CRADI is a sub score of PFDI-20
• Mean change from baseline in CRADI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  CRADI is a sub score of PFDI-20
• Mean UDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  UDI is a sub score of PFDI-20
• Mean UDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  UDI is a sub score of PFDI-20
• Mean change from baseline in UDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  UDI is a sub score of PFDI-20
• Mean change from baseline in UDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  UDI is a sub score of PFDI-20
• EuroQol (EQ-5D health state) change from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• EuroQol (EQ-5D health state) change from baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Mean PFIQ-7 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Mean PFIQ-7 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Mean change from baseline in PFIQ-7 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Mean change from baseline in PFIQ-7 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Mean POPIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  POPIQ is a sub-score of PFIQ-7
• Mean POPIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  POPIQ is a sub-score of PFIQ-7
• Mean change from baseline in POPIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  POPIQ is a sub-score of PFIQ-7
• Mean change from baseline in POPIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  POPIQ is a sub-score of PFIQ-7
• Mean CRAIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  CRAIQ is a sub-score of PFIQ-7
• Mean CRAIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  CRAIQ is a sub-score of PFIQ-7
• Mean change from baseline in CRAIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  CRAIQ is a sub-score of PFIQ-7
• Mean change from baseline in CRAIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  CRAIQ is a sub-score of PFIQ-7
• Mean UIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  UIQ is a sub-score of PFIQ-7
• Mean UIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  UIQ is a sub-score of PFIQ-7
• Mean change from baseline in UIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  UIQ is a sub-score of PFIQ-7
• Mean change from baseline in UIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  UIQ is a sub-score of PFIQ-7
• Mean PISQ-12 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  In subjects sexually active at baseline, assessment of sexual function
• Mean PISQ-12 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  In subjects sexually active at baseline, assessment of sexual function
• Mean change from baseline in PISQ-12 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  In subjects sexually active at baseline, assessment of sexual function
• Mean change from baseline in PISQ-12 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  In subjects sexually active at baseline, assessment of sexual function
• Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
• Length of procedure [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
  From time to first incision to time of last suture used to secure VSD
• Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 24 hours post surgery and at the 3-4 week visit ] [ Designated as safety issue: Yes ]
• Discomfort of balloon removal, measured using VAS at time of removal. [ Time Frame: 24 hrs post-surgical ] [ Designated as safety issue: Yes ]
• Subject perception of VSD: Awareness [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
  Measured by visual analogue scale
• Subject perception of VSD: Discomfort [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
  Measured by visual analogue scale
• Subject perception of VSD: Acceptability of discharge [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
  Measured by visual analogue scale
• Subject global impression [ Time Frame: 12 month visit ] [ Designated as safety issue: No ]
  assessed on a 5 point Likert scale
• Subject global impression [ Time Frame: 24 month visit ] [ Designated as safety issue: No ]
  assessed on a 5 point Likert scale

• Summary of ICS Stages at 6 month visit.
• Summary of treated compartment ICS POP-Q stage at 6 and 12 months.
• Success at 12 months, defined as the leading edge within the hymen
• Mean scores and change from baseline in PFDI-20 scores at 6 and 12 month visits including sub scores (POPDI, CRADI and UDI).
• Date of return to normal activities
• EuroQol (EQ-5D health state) change from baseline at 6 and 12 months visit.
• Mean scores and change from baseline in PFIQ-7 at 6 and 12 months visit including sub scores (POPIQ, CRAIQ and UIQ).
• In subjects sexually active at baseline, assessment of sexual function using PISQ-12 assessed at 6 and 12 month visits (mean scores and change from baseline).
• Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
• Total time in the operating room.
• Length of procedure
• Nights in hospital
• Pain score 24 hours post surgery and at the 3-4 week visit, measured using Visual Analog Scale (VAS).
• Discomfort of balloon removal, measured using VAS at time of removal.
• Subject perception of VSD by VAS at 3-4 week visit, assessing incidence of VSD displacement.
• Balloon performance as measured by inflation volume at time of removal versus original volume used for balloon inflation.
• Subject global impression assessed on a 5 point Likert scale at 6 and 12 month visit.
• Comparison of POP-Q success rates in DRI versus non-DRI subjects.
• Assessment of vaginal mesh placement using 3-D ultrasound scanning

The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.

(*TRADEMARK)

The GYNECARE PROSIMA* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.

Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair

Inclusion Criteria:

• Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.
• Age ≥ 18 years.
• Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.

Exclusion Criteria:

• Additional surgical intervention concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
• Previous repair of pelvic organ prolapse involving insertion of mesh.
• Previous hysterectomy within 6 months of scheduled surgery.
• Experimental drug or experimental medical device within 3 months prior to the planned procedure.
• Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
• Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
• History of chemotherapy or pelvic radiation therapy.
• Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
• Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
• Nursing or pregnant or intends future pregnancy.
• In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.