We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01396122
First Posted: July 18, 2011
Last Update Posted: December 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peking Union Medical College Hospital
July 13, 2011
July 18, 2011
December 27, 2012
March 2011
March 2016   (Final data collection date for primary outcome measure)
  • Anatomical improvement according to POP-Q score. [ Time Frame: 4 weeks ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 6 months ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 12 months ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 2 years ]
  • Anatomical improvement according to POP-Q score. [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01396122 on ClinicalTrials.gov Archive Site
  • 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. ]
  • Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 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. ]
  • Subject discomfort of VSD by VAS. [ Time Frame: 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.
  • Change from baseline in PFIQ-7 scores. [ Time Frame: 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). [ Time Frame: 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. ]
  • 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.
Same as current
Not Provided
Not Provided
 
Clinical Performance of GYNECARE PROSIMA* Pelvic Floor Repair System for Symptomatic Pelvic Organ Prolapse
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pelvic Organ Prolapse
  • Stage II-III
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.
Experimental: PROSIMA group
Reconstructive surgeries with GYNECARE PROSIMA* were performed in all patients.
Intervention: Procedure: Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
March 2016
March 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01396122
pumch-gyn-02
No
Not Provided
Not Provided
Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Principal Investigator: Lan Zhu Peking Union Medical College Hospital
Peking Union Medical College Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP