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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01396122
First received: July 13, 2011
Last updated: December 25, 2012
Last verified: July 2011
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Stage II-III
Procedure: Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Anatomical improvement according to POP-Q score. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital data including operative time, estimated blood loss, length of stay, maximum temperature, time of voiding recovery. [ Time Frame: At discharge, an expected average of 5 days after operation. ] [ Designated as safety issue: Yes ]
  • Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 24 hours after surgery and postoperation visit at the 3-4 weeks. ] [ Designated as safety issue: Yes ]
  • Discomfort of balloon removal, measured using VAS at time of removal. [ Time Frame: 24 hours after surgery. ] [ Designated as safety issue: Yes ]
  • Subject discomfort of VSD by VAS. [ Time Frame: postoperation visit at 3-4 weeks. ] [ Designated as safety issue: Yes ]
  • Presence/absence of complications (composite score) [ Time Frame: Up to 6 weeks. ] [ Designated as safety issue: Yes ]
    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.

  • Change from baseline in PFIQ-7 scores. [ Time Frame: 6 months, 12 months, 2 years and 3 years. ] [ Designated as safety issue: No ]
  • In subjects sexually active at baseline, assessment of sexual function using PISQ-12 (mean scores and change from baseline). [ Time Frame: 6 months, 12 months, 2 years and 3 years. ] [ Designated as safety issue: No ]
  • Subject global impression assessed on a 5 point Likert scale. [ Time Frame: 6 months, 12 months, 2 years and 3 years. ] [ Designated as safety issue: No ]
  • Presence/absence of complications (composite score) [ Time Frame: Up to 3 years. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROSIMA group
Reconstructive surgeries with GYNECARE PROSIMA* were performed in all patients.
Procedure: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396122

Contacts
Contact: Lan Zhu 86-10-65296238 zhu_julie@vip.sina.com
Contact: Juan Chen 86-13521354364 pumchcj@sina.com

Locations
China, Fujian
Fujian Provincial Hospital Active, not recruiting
Fuzhou, Fujian, China, 350001
The First Affiliated Hospital of Fujian Medical University Active, not recruiting
Fuzhou, Fujian, China, 350005
Xiamen First Hospital Affiliated to Xiamen University Recruiting
Xiamen, Fujian, China, 361004
Contact: Na-xuan Qiu    13906011647    qnx1106@sina.com   
Principal Investigator: Na-xuan Qiu         
China, Guangdong
The First People's Hospital of Foshan Not yet recruiting
Foshan, Guangdong, China, 528000
Contact: Gang Wang    86-13929928768    Wallace1971@163.com   
Principal Investigator: Gang Wang         
The First Hospital of Sun Yat-sen University Active, not recruiting
Guangzhou, Guangdong, China, 510080
The First Affiliated Hospital of Guangzhou Medical College Active, not recruiting
Guangzhou, Guangdong, China, 510120
Peking University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China, 518036
Contact: Rui-fang Wu    86-13827433039    Wurf100@126.com   
Contact: Huan Li    86-13828700921    szbdlh@163.com   
Principal Investigator: Rui-fang Wu         
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Active, not recruiting
Harbin, Heilongjiang, China, 150001
China, Hubei
The People's Hospital of Hubei Provincial Active, not recruiting
Wuhan, Hubei, China, 430060
The Third Hospital of Wuhan Active, not recruiting
Wuhan, Hubei, China, 430060
China, Hunan
The Second Hospital of Xiangya,Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Guang-shi Tao    86-13574850167    taoguangshi@yahoo.com.cn   
Principal Investigator: Guang-shi Tao         
China, Jiangsu
The First Hospital Affiliated to Nanjing Medical University Active, not recruiting
Nanjing, Jiangsu, China, 210006
Wuxi Maternal and Child Health Hospital, Nanjing Medical University Recruiting
Wuxi, Jiangsu, China, 214002
Contact: Jian Gong    86-13812074116    gongjianwx@126.com   
Principal Investigator: Jian Gong         
China, Liaoning
Affiliated Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Zhi-jun Xia    86-13840118800    xiazhijunhosp2@sina.com   
Contact: Qing Hu    86-18940255559    huq@sj-hospital.org   
Principal Investigator: Zhi-jun Xia         
China, Shandong
The Second Affiliated Hospital, Shandong University Active, not recruiting
Jinan, Shandong, China, 250033
China, Sichuan
The Fifth People' Hospital of Chengdu Active, not recruiting
Chengdu, Sichuan, China, 611130
Sichuan Provincial People's Hospital Active, not recruiting
Chengdu, Sichuan, China, 610072
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Hong Shen    86-18980601433    shen1177@163.com   
Principal Investigator: Hong Shen         
West China Second Hospital of Sichuan University Active, not recruiting
Chengdu, Sichuan, China, 610041
Mianyang Central Hospital Recruiting
Mianyang, Sichuan, China, 621000
Contact: Yong Zhang    86-13808110138    Zhangyong1215@gmail.com   
Principal Investigator: Yong Zhang         
China
Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences Recruiting
Beijing, China, 100020
Contact: Zhenyu Zhang    86-13801237287    Zhenyuzhang2000@yahoo.com   
Contact: Hong Wang    86-13683690370      
Principal Investigator: Zhenyu Zhang         
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Lan Zhu    86-10-65296238    zhu_julie@vip.sina.com   
Contact: Juan Chen    86-13521354364    pumchcj@sina.com   
Principal Investigator: Lan Zhu         
The First Affiliated Hospital of Chinese PLA General Hospital Recruiting
Beijing, China, 100048
Contact: Yong-xian Lu    86-13520476024    Yongxianlu@sina.com   
Principal Investigator: Yong-xina Lu         
Beijing Hospital Active, not recruiting
Beijing, China, 100730
The First Hospital of Chongqing Medical University Active, not recruiting
Chongqin, China, 400016
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Lan Zhu Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01396122     History of Changes
Other Study ID Numbers: pumch-gyn-02
Study First Received: July 13, 2011
Last Updated: December 25, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014