GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Device: GYNECARE PROSIMA* Pelvic Floor Repair System
- Registration Number
- NCT00521066
- Lead Sponsor
- Ethicon, Inc.
- Brief Summary
The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA\* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.
(\*TRADEMARK)
- Detailed Description
The GYNECARE PROSIMA\* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or 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 / IRB approved informed consent.
- Additional surgical intervention concurrent to the PROSIMA 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, spina bifida, 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 GYNECARE PROSIMA* Pelvic Floor Repair System Prosima Pelvic Floor Repair System
- Primary Outcome Measures
Name Time Method Success based on overall POP-Q score at 12 months post-procedure. 12-months Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
- Secondary Outcome Measures
Name Time Method Mean change from baseline in PISQ-12 score 24 months In subjects sexually active at baseline, assessment of sexual function
Success based on treated compartment ICS POP-Q stage 24 months Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
Mean PFDI-20 score 24 months Mean change from baseline in PFDI-20 scores 12 months Mean change from baseline in POPDI score 24 months POPDI is a sub score of PFDI-20
Mean change from baseline in CRADI score 24 months CRADI is a sub score of PFDI-20
Mean CRAIQ score 24 months CRAIQ is a sub-score of PFIQ-7
Mean PISQ-12 score 24 months In subjects sexually active at baseline, assessment of sexual function
Mean POPIQ score 24 months POPIQ is a sub-score of PFIQ-7
Mean change from baseline in UIQ score 24 months UIQ is a sub-score of PFIQ-7
Discomfort of balloon removal, measured using VAS at time of removal. 24 hrs post-surgical Subject perception of VSD: Awareness 3-4 week visit Measured by visual analogue scale
Success based on overall POP-Q score at 24 months post-procedure. 24 months Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP
Success defined as the leading edge within the hymen 24 months Success defined as the leading edge within the hymen (i.e. all POP-Q values to be less than 0, without further re-intervention for POP)
EuroQol (EQ-5D health state) change from baseline 24 months Mean change from baseline in CRAIQ score 24 months CRAIQ is a sub-score of PFIQ-7
Mean UIQ score 24 months UIQ is a sub-score of PFIQ-7
Mean POPDI score 24 months POPDI is a sub score of PFDI-20
Mean UDI score 24 months UDI is a sub score of PFDI-20
Mean change from baseline in UDI score 24 months UDI is a sub score of PFDI-20
Mean PFIQ-7 score 24 months Mean change from baseline in PFIQ-7 score 24 months Subject perception of VSD: Discomfort 3-4 week visit Measured by visual analogue scale
Mean CRADI score 24 months CRADI is a sub score of PFDI-20
Mean change from baseline in POPIQ score 24 months POPIQ is a sub-score of PFIQ-7
Pain score measured using Visual Analog Scale (VAS). 24 hours post surgery and at the 3-4 week visit Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia ongoing Length of procedure perioperative From time to first incision to time of last suture used to secure VSD
Subject perception of VSD: Acceptability of discharge 3-4 week visit Measured by visual analogue scale
Subject global impression 24 month visit assessed on a 5 point Likert scale
Trial Locations
- Locations (11)
Female Pelvic Medicine and Urogynecology Institute of Michigan
🇺🇸Dearborn, Michigan, United States
Specialists in Urology
🇺🇸Naples, Florida, United States
Universitatsklinik Tubingen
🇩🇪Tubingen, Germany
Female Pelvic Medicine & Urogynecology
🇺🇸Grand Rapids, Michigan, United States
St. Mary's Hospital
🇬🇧Manchester, United Kingdom
Magee Women's Hospital of the Universtiy of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
The Institute for Female Pelvic Medicine & Reconstructive Surgery
🇺🇸Allentown, Pennsylvania, United States
Royal Women's Hospital
🇦🇺Melbourne, Australia
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Bereich Urogynakologie
🇩🇪Halle, Germany
North Hampshire Hospital
🇬🇧Hampshire, United Kingdom