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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROSIMA group | Experimental | Reconstructive surgeries with GYNECARE PROSIMA* were performed in all patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System | Procedure | Perform surgery with GYNECARE PROSIMA* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhu | Contact | 86-10-65296238 | zhu_julie@vip.sina.com | |
| Juan Chen | Contact | 86-13521354364 | pumchcj@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhu | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Active, not recruiting | Fuzhou | Fujian | 350001 | China | |
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| 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. |
| The First Affiliated Hospital of Fujian Medical University |
| Active, not recruiting |
| Fuzhou |
| Fujian |
| 350005 |
| China |
| Xiamen First Hospital Affiliated to Xiamen University | Recruiting | Xiamen | Fujian | 361004 | China |
|
| The First People's Hospital of Foshan | Not yet recruiting | Foshan | Guangdong | 528000 | China |
|
| The First Hospital of Sun Yat-sen University | Active, not recruiting | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital of Guangzhou Medical College | Active, not recruiting | Guangzhou | Guangdong | 510120 | China |
| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | 518036 | China |
|
| The First Affiliated Hospital of Harbin Medical University | Active, not recruiting | Harbin | Heilongjiang | 150001 | China |
| The People's Hospital of Hubei Provincial | Active, not recruiting | Wuhan | Hubei | 430060 | China |
| The Third Hospital of Wuhan | Active, not recruiting | Wuhan | Hubei | 430060 | China |
| The Second Hospital of Xiangya,Central South University | Recruiting | Changsha | Hunan | 410011 | China |
|
| The First Hospital Affiliated to Nanjing Medical University | Active, not recruiting | Nanjing | Jiangsu | 210006 | China |
| Wuxi Maternal and Child Health Hospital, Nanjing Medical University | Recruiting | Wuxi | Jiangsu | 214002 | China |
|
| Affiliated Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110004 | China |
|
| The Second Affiliated Hospital, Shandong University | Active, not recruiting | Jinan | Shandong | 250033 | China |
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| West China Second Hospital of Sichuan University | Active, not recruiting | Chengdu | Sichuan | 610041 | China |
| Sichuan Provincial People's Hospital | Active, not recruiting | Chengdu | Sichuan | 610072 | China |
| The Fifth People' Hospital of Chengdu | Active, not recruiting | Chengdu | Sichuan | 611130 | China |
| Mianyang Central Hospital | Recruiting | Mianyang | Sichuan | 621000 | China |
|
| Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences | Recruiting | Beijing | 100020 | China |
|
| The First Affiliated Hospital of Chinese PLA General Hospital | Recruiting | Beijing | 100048 | China |
|
| Beijing Hospital | Active, not recruiting | Beijing | 100730 | China |
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
|
| The First Hospital of Chongqing Medical University | Active, not recruiting | Chongqin | 400016 | China |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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