GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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)

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

Official Title
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A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: GYNECARE PROSIMA* Pelvic Floor Repair System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Prosima Pelvic Floor Repair System | Device: GYNECARE PROSIMA* Pelvic Floor Repair System<br>* procedure for pelvic organ prolapse<br>* Other names: mesh pelvic floor repari;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success based on overall POP-Q score at 12 months post-procedure. | Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP. | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success based on overall POP-Q score at 24 months post-procedure. | Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP | 24 months | 
| Success based on treated compartment ICS POP-Q stage | Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP. | 12 months | 
| Success based on treated compartment ICS POP-Q stage | Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP. | 24 months | 
| Success defined as the leading edge within the hymen | 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) | 12 months | 
| Success defined as the leading edge within the hymen | 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) | 24 months | 
| Mean PFDI-20 score |  | 12 months | 
| Mean PFDI-20 score |  | 24 months | 
| Mean change from baseline in PFDI-20 scores |  | 24 months | 
| Mean change from baseline in PFDI-20 scores |  | 12 months | 
| Mean POPDI score | POPDI is a sub score of PFDI-20 | 12 months | 
| Mean POPDI score | POPDI is a sub score of PFDI-20 | 24 months | 
| Mean change from baseline in POPDI score | POPDI is a sub scores of PFDI-20 | 12 months | 
| Mean change from baseline in POPDI score | POPDI is a sub score of PFDI-20 | 24 months | 
| Mean CRADI score | CRADI is a sub score of PFDI-20 | 12 months | 
| Mean CRADI score | CRADI is a sub score of PFDI-20 | 24 months | 
| Mean change from baseline in CRADI score | CRADI is a sub score of PFDI-20 | 12 months | 
| Mean change from baseline in CRADI score | CRADI is a sub score of PFDI-20 | 24 months | 
| Mean UDI score | UDI is a sub score of PFDI-20 | 12 months | 
| Mean UDI score | UDI is a sub score of PFDI-20 | 24 months | 
| Mean change from baseline in UDI score | UDI is a sub score of PFDI-20 | 12 months | 
| Mean change from baseline in UDI score | UDI is a sub score of PFDI-20 | 24 months | 
| EuroQol (EQ-5D health state) change from baseline |  | 12 months | 
| EuroQol (EQ-5D health state) change from baseline |  | 24 months | 
| Mean PFIQ-7 score |  | 12 months | 
| Mean PFIQ-7 score |  | 24 months | 
| Mean change from baseline in PFIQ-7 score |  | 12 months | 
| Mean change from baseline in PFIQ-7 score |  | 24 months | 
| Mean POPIQ score | POPIQ is a sub-score of PFIQ-7 | 12 months | 
| Mean POPIQ score | POPIQ is a sub-score of PFIQ-7 | 24 months | 
| Mean change from baseline in POPIQ score | POPIQ is a sub-score of PFIQ-7 | 12 months | 
| Mean change from baseline in POPIQ score | POPIQ is a sub-score of PFIQ-7 | 24 months | 
| Mean CRAIQ score | CRAIQ is a sub-score of PFIQ-7 | 12 months | 
| Mean CRAIQ score | CRAIQ is a sub-score of PFIQ-7 | 24 months | 
| Mean change from baseline in CRAIQ score | CRAIQ is a sub-score of PFIQ-7 | 12 months | 
| Mean change from baseline in CRAIQ score | CRAIQ is a sub-score of PFIQ-7 | 24 months | 
| Mean UIQ score | UIQ is a sub-score of PFIQ-7 | 12 months | 
| Mean UIQ score | UIQ is a sub-score of PFIQ-7 | 24 months | 
| Mean change from baseline in UIQ score | UIQ is a sub-score of PFIQ-7 | 12 months | 
| Mean change from baseline in UIQ score | UIQ is a sub-score of PFIQ-7 | 24 months | 
| Mean PISQ-12 score | In subjects sexually active at baseline, assessment of sexual function | 12 months | 
| Mean PISQ-12 score | In subjects sexually active at baseline, assessment of sexual function | 24 months | 
| Mean change from baseline in PISQ-12 score | In subjects sexually active at baseline, assessment of sexual function | 12 months | 
| Mean change from baseline in PISQ-12 score | In subjects sexually active at baseline, assessment of sexual function | 24 months | 
| Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia |  | ongoing | 
| Length of procedure | From time to first incision to time of last suture used to secure VSD | perioperative | 
| Pain score measured using Visual Analog Scale (VAS). |  | 24 hours post surgery and at the 3-4 week visit | 
| Discomfort of balloon removal, measured using VAS at time of removal. |  | 24 hrs post-surgical | 
| Subject perception of VSD: Awareness | Measured by visual analogue scale | 3-4 week visit | 
| Subject perception of VSD: Discomfort | Measured by visual analogue scale | 3-4 week visit | 
| Subject perception of VSD: Acceptability of discharge | Measured by visual analogue scale | 3-4 week visit | 
| Subject global impression | assessed on a 5 point Likert scale | 12 month visit | 
| Subject global impression | assessed on a 5 point Likert scale | 24 month visit |