Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse
NCT ID: NCT01396122
Last Updated: 2012-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2011-03-31
2016-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PROSIMA group
Reconstructive surgeries with GYNECARE PROSIMA\* were performed in all patients.
Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System
Perform surgery with GYNECARE PROSIMA\* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently.
Interventions
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Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System
Perform surgery with GYNECARE PROSIMA\* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Lan Zhu
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Fujian Provincial Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Xiamen First Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
The First Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The People's Hospital of Hubei Provincial
Wuhan, Hubei, China
The Third Hospital of Wuhan
Wuhan, Hubei, China
The Second Hospital of Xiangya,Central South University
Changsha, Hunan, China
The First Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Wuxi Maternal and Child Health Hospital, Nanjing Medical University
Wuxi, Jiangsu, China
Affiliated Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The Second Affiliated Hospital, Shandong University
Jinan, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Fifth People' Hospital of Chengdu
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences
Beijing, , China
The First Affiliated Hospital of Chinese PLA General Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The First Hospital of Chongqing Medical University
Chongqin, , China
Countries
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Central Contacts
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Facility Contacts
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Na-xuan Qiu
Role: primary
Gang Wang
Role: primary
Rui-fang Wu
Role: primary
Huan Li
Role: backup
Guang-shi Tao
Role: primary
Jian Gong
Role: primary
Zhi-jun Xia
Role: primary
Qing Hu
Role: backup
Hong Shen
Role: primary
Yong Zhang
Role: primary
Zhenyu Zhang
Role: primary
Hong Wang
Role: backup
Yong-xian Lu
Role: primary
Lan Zhu
Role: primary
Juan Chen
Role: backup
Other Identifiers
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pumch-gyn-02
Identifier Type: -
Identifier Source: org_study_id