GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00521066
First received: August 24, 2007
Last updated: May 5, 2014
Last verified: May 2014

August 24, 2007
May 5, 2014
June 2007
October 2008   (final data collection date for primary outcome measure)
Success based on overall POP-Q score at 12 months post-procedure. [ Time Frame: 12-months ] [ Designated as safety issue: No ]
Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
POP-Q score at 12 months post-procedure. [ Time Frame: 12-months ]
Complete list of historical versions of study NCT00521066 on ClinicalTrials.gov Archive Site
  • Success based on overall POP-Q score at 24 months post-procedure. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Success is determined by achievement of an overall POP-Q score of ICS Stage ≤1, without further re-intervention for POP
  • Success based on treated compartment ICS POP-Q stage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
  • Success based on treated compartment ICS POP-Q stage [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Success will be determined by achievement of treated compartment POP-Q score of ICS Stage ≤1, without further re-intervention for POP.
  • Success defined as the leading edge within the hymen [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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)
  • Success defined as the leading edge within the hymen [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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)
  • Mean PFDI-20 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean PFDI-20 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in PFDI-20 scores [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in PFDI-20 scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean POPDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    POPDI is a sub score of PFDI-20
  • Mean POPDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    POPDI is a sub score of PFDI-20
  • Mean change from baseline in POPDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    POPDI is a sub scores of PFDI-20
  • Mean change from baseline in POPDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    POPDI is a sub score of PFDI-20
  • Mean CRADI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CRADI is a sub score of PFDI-20
  • Mean CRADI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CRADI is a sub score of PFDI-20
  • Mean change from baseline in CRADI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CRADI is a sub score of PFDI-20
  • Mean change from baseline in CRADI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CRADI is a sub score of PFDI-20
  • Mean UDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UDI is a sub score of PFDI-20
  • Mean UDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    UDI is a sub score of PFDI-20
  • Mean change from baseline in UDI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UDI is a sub score of PFDI-20
  • Mean change from baseline in UDI score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    UDI is a sub score of PFDI-20
  • EuroQol (EQ-5D health state) change from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • EuroQol (EQ-5D health state) change from baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean PFIQ-7 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean PFIQ-7 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in PFIQ-7 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean change from baseline in PFIQ-7 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Mean POPIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    POPIQ is a sub-score of PFIQ-7
  • Mean POPIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    POPIQ is a sub-score of PFIQ-7
  • Mean change from baseline in POPIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    POPIQ is a sub-score of PFIQ-7
  • Mean change from baseline in POPIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    POPIQ is a sub-score of PFIQ-7
  • Mean CRAIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CRAIQ is a sub-score of PFIQ-7
  • Mean CRAIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CRAIQ is a sub-score of PFIQ-7
  • Mean change from baseline in CRAIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CRAIQ is a sub-score of PFIQ-7
  • Mean change from baseline in CRAIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CRAIQ is a sub-score of PFIQ-7
  • Mean UIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UIQ is a sub-score of PFIQ-7
  • Mean UIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    UIQ is a sub-score of PFIQ-7
  • Mean change from baseline in UIQ score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    UIQ is a sub-score of PFIQ-7
  • Mean change from baseline in UIQ score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    UIQ is a sub-score of PFIQ-7
  • Mean PISQ-12 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    In subjects sexually active at baseline, assessment of sexual function
  • Mean PISQ-12 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    In subjects sexually active at baseline, assessment of sexual function
  • Mean change from baseline in PISQ-12 score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    In subjects sexually active at baseline, assessment of sexual function
  • Mean change from baseline in PISQ-12 score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    In subjects sexually active at baseline, assessment of sexual function
  • Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Length of procedure [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
    From time to first incision to time of last suture used to secure VSD
  • Pain score measured using Visual Analog Scale (VAS). [ Time Frame: 24 hours post surgery and at the 3-4 week visit ] [ Designated as safety issue: Yes ]
  • Discomfort of balloon removal, measured using VAS at time of removal. [ Time Frame: 24 hrs post-surgical ] [ Designated as safety issue: Yes ]
  • Subject perception of VSD: Awareness [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
    Measured by visual analogue scale
  • Subject perception of VSD: Discomfort [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
    Measured by visual analogue scale
  • Subject perception of VSD: Acceptability of discharge [ Time Frame: 3-4 week visit ] [ Designated as safety issue: No ]
    Measured by visual analogue scale
  • Subject global impression [ Time Frame: 12 month visit ] [ Designated as safety issue: No ]
    assessed on a 5 point Likert scale
  • Subject global impression [ Time Frame: 24 month visit ] [ Designated as safety issue: No ]
    assessed on a 5 point Likert scale
  • Summary of ICS Stages at 6 month visit.
  • Summary of treated compartment ICS POP-Q stage at 6 and 12 months.
  • Success at 12 months, defined as the leading edge within the hymen
  • Mean scores and change from baseline in PFDI-20 scores at 6 and 12 month visits including sub scores (POPDI, CRADI and UDI).
  • Date of return to normal activities
  • EuroQol (EQ-5D health state) change from baseline at 6 and 12 months visit.
  • Mean scores and change from baseline in PFIQ-7 at 6 and 12 months visit including sub scores (POPIQ, CRAIQ and UIQ).
  • In subjects sexually active at baseline, assessment of sexual function using PISQ-12 assessed at 6 and 12 month visits (mean scores and change from baseline).
  • Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
  • Total time in the operating room.
  • Length of procedure
  • Nights in hospital
  • Pain score 24 hours post surgery and at the 3-4 week visit, measured using Visual Analog Scale (VAS).
  • Discomfort of balloon removal, measured using VAS at time of removal.
  • Subject perception of VSD by VAS at 3-4 week visit, assessing incidence of VSD displacement.
  • Balloon performance as measured by inflation volume at time of removal versus original volume used for balloon inflation.
  • Subject global impression assessed on a 5 point Likert scale at 6 and 12 month visit.
  • Comparison of POP-Q success rates in DRI versus non-DRI subjects.
  • Assessment of vaginal mesh placement using 3-D ultrasound scanning
Not Provided
Not Provided
 
GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse

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)

The GYNECARE PROSIMA* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair

Pelvic Organ Prolapse
Device: GYNECARE PROSIMA* Pelvic Floor Repair System
procedure for pelvic organ prolapse
Other Name: mesh pelvic floor repari
1
Prosima Pelvic Floor Repair System
Intervention: Device: GYNECARE PROSIMA* Pelvic Floor Repair System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2010
October 2008   (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, 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.

Exclusion Criteria:

  • 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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Germany,   United States,   Australia
 
NCT00521066
300-06-005
No
Ethicon, Inc.
Ethicon, Inc.
Not Provided
Study Director: David Robinson, M.D. Ethicon, Inc.
Ethicon, Inc.
May 2014

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