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

December 25, 2012 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Active, not recruiting
        • Beijing Hospital
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
      • Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital Affiliated to Capital University of Medical Sciences
        • Contact:
        • Contact:
          • Hong Wang
          • Phone Number: 86-13683690370
      • Beijing, China, 100048
        • Recruiting
        • The First Affiliated Hospital of Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Yong-xina Lu
      • Chongqin, China, 400016
        • Active, not recruiting
        • The first hospital of Chongqing medical university
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Active, not recruiting
        • Fujian Provincial Hospital
      • Fuzhou, Fujian, China, 350005
        • Active, not recruiting
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China, 361004
        • Recruiting
        • Xiamen First Hospital Affiliated to Xiamen University
        • Contact:
        • Principal Investigator:
          • Na-xuan Qiu
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Not yet recruiting
        • The First People's Hospital of Foshan
        • Contact:
        • Principal Investigator:
          • Gang Wang
      • Guangzhou, Guangdong, China, 510080
        • Active, not recruiting
        • The First Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510120
        • Active, not recruiting
        • The First Affiliated Hospital of Guangzhou Medical College
      • Shenzhen, Guangdong, China, 518036
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rui-fang Wu
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Active, not recruiting
        • The First Affiliated Hospital of Harbin Medical University
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Active, not recruiting
        • The People's Hospital of Hubei Provincial
      • Wuhan, Hubei, China, 430060
        • Active, not recruiting
        • The Third Hospital of Wuhan
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Hospital of Xiangya,Central South University
        • Contact:
        • Principal Investigator:
          • Guang-shi Tao
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Active, not recruiting
        • The First Hospital Affiliated to Nanjing Medical University
      • Wuxi, Jiangsu, China, 214002
        • Recruiting
        • Wuxi Maternal and Child Health Hospital, Nanjing Medical University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Affiliated Shengjing Hospital of China Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhi-jun Xia
    • Shandong
      • Jinan, Shandong, China, 250033
        • Active, not recruiting
        • The Second Affiliated Hospital, Shandong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Principal Investigator:
          • Hong SHEN
        • Contact:
      • Chengdu, Sichuan, China, 610041
        • Active, not recruiting
        • West China Second Hospital of Sichuan University
      • Chengdu, Sichuan, China, 610072
        • Active, not recruiting
        • Sichuan Provincial People's Hospital
      • Chengdu, Sichuan, China, 611130
        • Active, not recruiting
        • The Fifth People' Hospital of Chengdu
      • Mianyang, Sichuan, China, 621000
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
        • Principal Investigator:
          • Yong Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anatomical improvement according to POP-Q score.
Time Frame: 4 weeks
4 weeks
Anatomical improvement according to POP-Q score.
Time Frame: 6 months
6 months
Anatomical improvement according to POP-Q score.
Time Frame: 12 months
12 months
Anatomical improvement according to POP-Q score.
Time Frame: 2 years
2 years
Anatomical improvement according to POP-Q score.
Time Frame: 3 years
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.
Time Frame: At discharge, an expected average of 5 days after operation.
At discharge, an expected average of 5 days after operation.
Change from baseline in PFIQ-7 scores.
Time Frame: 6 months, 12 months, 2 years and 3 years.
6 months, 12 months, 2 years and 3 years.
Presence/absence of complications (composite score)
Time Frame: Up to 3 years.
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.
Pain score measured using Visual Analog Scale (VAS).
Time Frame: 24 hours after surgery and postoperation visit at the 3-4 weeks.
24 hours after surgery and postoperation visit at the 3-4 weeks.
Discomfort of balloon removal, measured using VAS at time of removal.
Time Frame: 24 hours after surgery.
24 hours after surgery.
Subject discomfort of VSD by VAS.
Time Frame: postoperation visit at 3-4 weeks.
postoperation visit at 3-4 weeks.
Presence/absence of complications (composite score)
Time Frame: Up to 6 weeks.
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.
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.
6 months, 12 months, 2 years and 3 years.
Subject global impression assessed on a 5 point Likert scale.
Time Frame: 6 months, 12 months, 2 years and 3 years.
6 months, 12 months, 2 years and 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

December 27, 2012

Last Update Submitted That Met QC Criteria

December 25, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pumch-gyn-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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