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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
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   (Adult, Senior)
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

Locations
China, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Xiamen First Hospital Affiliated to Xiamen University
Xiamen, Fujian, China, 361004
China, Guangdong
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
The First Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510120
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
China, Hubei
The People's Hospital of Hubei Provincial
Wuhan, Hubei, China, 430060
The Third Hospital of Wuhan
Wuhan, Hubei, China, 430060
China, Hunan
The Second Hospital of Xiangya,Central South University
Changsha, Hunan, China, 410011
China, Jiangsu
The First Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China, 210006
Wuxi Maternal and Child Health Hospital, Nanjing Medical University
Wuxi, Jiangsu, China, 214002
China, Liaoning
Affiliated Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
China, Shandong
The Second Affiliated Hospital, Shandong University
Jinan, Shandong, China, 250033
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
The Fifth People' Hospital of Chengdu
Chengdu, Sichuan, China, 611130
Mianyang Central Hospital
Mianyang, Sichuan, China, 621000
China
Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences
Beijing, China, 100020
The First Affiliated Hospital of Chinese PLA General Hospital
Beijing, China, 100048
Beijing Hospital
Beijing, China, 100730
Peking Union Medical College Hospital
Beijing, China, 100730
The First Hospital of Chongqing Medical University
Chongqin, China, 400016
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Lan Zhu Peking Union Medical College Hospital
  More Information

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:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on December 02, 2016