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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Device in Women with Symptomatic Pelvic Organ Prolapse.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Symptomatic POP-Q Stage II-III Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse, Stage II-III

Intervention / Treatment
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* Procedure: Procedure: 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 and 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 approved informed consent. Exclusion Criteria: Additional surgical intervention concurrent to the 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, 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. Chronic cough not well-controlled. BMI≥30. 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROSIMA group<br>Reconstructive surgeries with GYNECARE PROSIMA* were performed in all patients. | Procedure: Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System<br>* Perform surgery with GYNECARE PROSIMA* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical improvement according to POP-Q score. |  | 4 weeks | 
| Anatomical improvement according to POP-Q score. |  | 6 months | 
| Anatomical improvement according to POP-Q score. |  | 12 months | 
| Anatomical improvement according to POP-Q score. |  | 2 years | 
| Anatomical improvement according to POP-Q score. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery. |  | At discharge, an expected average of 5 days after operation. | 
| Pain score measured using Visual Analog Scale (VAS). |  | 24 hours after surgery and postoperation visit at the 3-4 weeks. | 
| Discomfort of balloon removal, measured using VAS at time of removal. |  | 24 hours after surgery. | 
| Subject discomfort of VSD by VAS. |  | postoperation visit at 3-4 weeks. | 
| Presence/absence of complications (composite score) | 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. | Up to 6 weeks. | 
| Change from baseline in PFIQ-7 scores. |  | 6 months, 12 months, 2 years and 3 years. | 
| In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline). |  | 6 months, 12 months, 2 years and 3 years. | 
| Subject global impression assessed on a 5 point Likert scale. |  | 6 months, 12 months, 2 years and 3 years. | 
| Presence/absence of complications (composite score) | 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. | Up to 3 years. |