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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00521066
Registration number
NCT00521066
Ethics application status
Date submitted
24/08/2007
Date registered
27/08/2007
Date last updated
6/05/2014
Titles & IDs
Public title
GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
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Scientific title
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
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Secondary ID [1]
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300-06-005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Renal and Urogenital
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Other renal and urogenital disorders
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - GYNECARE PROSIMA* Pelvic Floor Repair System
1 - Prosima Pelvic Floor Repair System
Treatment: Devices: GYNECARE PROSIMA* Pelvic Floor Repair System
procedure for pelvic organ prolapse
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Success based on overall POP-Q score at 12 months post-procedure.
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Assessment method [1]
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Success is determined by achievement of an overall POP-Q score of ICS Stage =1, without further re-intervention for POP.
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Timepoint [1]
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12-months
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Secondary outcome [1]
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Success based on overall POP-Q score at 24 months post-procedure.
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Assessment method [1]
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Success is determined by achievement of an overall POP-Q score of ICS Stage =1, without further re-intervention for POP
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Success based on treated compartment ICS POP-Q stage
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Assessment method [2]
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Success will be determined by achievement of treated compartment POP-Q score of ICS Stage =1, without further re-intervention for POP.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Success based on treated compartment ICS POP-Q stage
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Assessment method [3]
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Success will be determined by achievement of treated compartment POP-Q score of ICS Stage =1, without further re-intervention for POP.
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Success defined as the leading edge within the hymen
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Assessment method [4]
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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)
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Success defined as the leading edge within the hymen
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Assessment method [5]
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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)
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Mean PFDI-20 score
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Assessment method [6]
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Mean PFDI-20 score
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Assessment method [7]
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Timepoint [7]
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24 months
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Secondary outcome [8]
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Mean change from baseline in PFDI-20 scores
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Assessment method [8]
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Timepoint [8]
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24 months
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Secondary outcome [9]
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Mean change from baseline in PFDI-20 scores
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Assessment method [9]
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Timepoint [9]
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12 months
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Secondary outcome [10]
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Mean POPDI score
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Assessment method [10]
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POPDI is a sub score of PFDI-20
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Timepoint [10]
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12 months
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Secondary outcome [11]
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Mean POPDI score
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Assessment method [11]
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POPDI is a sub score of PFDI-20
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Timepoint [11]
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24 months
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Secondary outcome [12]
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Mean change from baseline in POPDI score
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Assessment method [12]
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POPDI is a sub scores of PFDI-20
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Timepoint [12]
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12 months
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Secondary outcome [13]
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Mean change from baseline in POPDI score
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Assessment method [13]
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POPDI is a sub score of PFDI-20
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Timepoint [13]
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24 months
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Secondary outcome [14]
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Mean CRADI score
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Assessment method [14]
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CRADI is a sub score of PFDI-20
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Timepoint [14]
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12 months
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Secondary outcome [15]
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Mean CRADI score
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Assessment method [15]
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CRADI is a sub score of PFDI-20
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Timepoint [15]
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24 months
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Secondary outcome [16]
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Mean change from baseline in CRADI score
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Assessment method [16]
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CRADI is a sub score of PFDI-20
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Timepoint [16]
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12 months
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Secondary outcome [17]
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Mean change from baseline in CRADI score
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Assessment method [17]
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CRADI is a sub score of PFDI-20
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Timepoint [17]
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24 months
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Secondary outcome [18]
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Mean UDI score
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Assessment method [18]
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UDI is a sub score of PFDI-20
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Timepoint [18]
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12 months
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Secondary outcome [19]
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Mean UDI score
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Assessment method [19]
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UDI is a sub score of PFDI-20
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Timepoint [19]
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24 months
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Secondary outcome [20]
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Mean change from baseline in UDI score
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Assessment method [20]
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UDI is a sub score of PFDI-20
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Timepoint [20]
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12 months
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Secondary outcome [21]
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Mean change from baseline in UDI score
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Assessment method [21]
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UDI is a sub score of PFDI-20
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Timepoint [21]
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24 months
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Secondary outcome [22]
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EuroQol (EQ-5D health state) change from baseline
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Assessment method [22]
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0
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Timepoint [22]
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12 months
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Secondary outcome [23]
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EuroQol (EQ-5D health state) change from baseline
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Assessment method [23]
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Timepoint [23]
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24 months
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Secondary outcome [24]
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Mean PFIQ-7 score
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Assessment method [24]
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Timepoint [24]
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12 months
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Secondary outcome [25]
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Mean PFIQ-7 score
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Assessment method [25]
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Timepoint [25]
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24 months
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Secondary outcome [26]
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Mean change from baseline in PFIQ-7 score
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Assessment method [26]
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Timepoint [26]
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12 months
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Secondary outcome [27]
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Mean change from baseline in PFIQ-7 score
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Assessment method [27]
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Timepoint [27]
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24 months
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Secondary outcome [28]
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Mean POPIQ score
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Assessment method [28]
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POPIQ is a sub-score of PFIQ-7
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Timepoint [28]
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12 months
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Secondary outcome [29]
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Mean POPIQ score
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Assessment method [29]
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POPIQ is a sub-score of PFIQ-7
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Timepoint [29]
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24 months
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Secondary outcome [30]
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Mean change from baseline in POPIQ score
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Assessment method [30]
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POPIQ is a sub-score of PFIQ-7
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Timepoint [30]
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12 months
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Secondary outcome [31]
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Mean change from baseline in POPIQ score
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Assessment method [31]
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POPIQ is a sub-score of PFIQ-7
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Timepoint [31]
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24 months
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Secondary outcome [32]
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Mean CRAIQ score
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Assessment method [32]
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CRAIQ is a sub-score of PFIQ-7
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Timepoint [32]
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12 months
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Secondary outcome [33]
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Mean CRAIQ score
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Assessment method [33]
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CRAIQ is a sub-score of PFIQ-7
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Timepoint [33]
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24 months
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Secondary outcome [34]
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Mean change from baseline in CRAIQ score
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Assessment method [34]
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CRAIQ is a sub-score of PFIQ-7
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Timepoint [34]
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12 months
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Secondary outcome [35]
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Mean change from baseline in CRAIQ score
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Assessment method [35]
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CRAIQ is a sub-score of PFIQ-7
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Timepoint [35]
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24 months
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Secondary outcome [36]
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Mean UIQ score
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Assessment method [36]
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UIQ is a sub-score of PFIQ-7
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Timepoint [36]
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12 months
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Secondary outcome [37]
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Mean UIQ score
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Assessment method [37]
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UIQ is a sub-score of PFIQ-7
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Timepoint [37]
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24 months
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Secondary outcome [38]
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Mean change from baseline in UIQ score
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Assessment method [38]
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UIQ is a sub-score of PFIQ-7
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Timepoint [38]
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12 months
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Secondary outcome [39]
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Mean change from baseline in UIQ score
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Assessment method [39]
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UIQ is a sub-score of PFIQ-7
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Timepoint [39]
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24 months
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Secondary outcome [40]
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Mean PISQ-12 score
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Assessment method [40]
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In subjects sexually active at baseline, assessment of sexual function
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Timepoint [40]
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12 months
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Secondary outcome [41]
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Mean PISQ-12 score
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Assessment method [41]
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In subjects sexually active at baseline, assessment of sexual function
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Timepoint [41]
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24 months
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Secondary outcome [42]
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Mean change from baseline in PISQ-12 score
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Assessment method [42]
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In subjects sexually active at baseline, assessment of sexual function
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Timepoint [42]
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12 months
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Secondary outcome [43]
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Mean change from baseline in PISQ-12 score
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Assessment method [43]
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In subjects sexually active at baseline, assessment of sexual function
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Timepoint [43]
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24 months
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Secondary outcome [44]
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Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
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Assessment method [44]
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Timepoint [44]
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ongoing
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Secondary outcome [45]
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Length of procedure
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Assessment method [45]
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From time to first incision to time of last suture used to secure VSD
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Timepoint [45]
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perioperative
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Secondary outcome [46]
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Pain score measured using Visual Analog Scale (VAS).
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Assessment method [46]
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Timepoint [46]
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24 hours post surgery and at the 3-4 week visit
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Secondary outcome [47]
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Discomfort of balloon removal, measured using VAS at time of removal.
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Assessment method [47]
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Timepoint [47]
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24 hrs post-surgical
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Secondary outcome [48]
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Subject perception of VSD: Awareness
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Assessment method [48]
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Measured by visual analogue scale
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Timepoint [48]
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3-4 week visit
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Secondary outcome [49]
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Subject perception of VSD: Discomfort
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Assessment method [49]
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Measured by visual analogue scale
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Timepoint [49]
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3-4 week visit
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Secondary outcome [50]
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Subject perception of VSD: Acceptability of discharge
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Assessment method [50]
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Measured by visual analogue scale
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Timepoint [50]
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3-4 week visit
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Secondary outcome [51]
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Subject global impression
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Assessment method [51]
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assessed on a 5 point Likert scale
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Timepoint [51]
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12 month visit
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Secondary outcome [52]
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Subject global impression
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Assessment method [52]
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assessed on a 5 point Likert scale
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Timepoint [52]
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24 month visit
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
150
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Women's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3053 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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0
United States of America
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State/province [2]
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Michigan
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Country [3]
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0
United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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0
Germany
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State/province [4]
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Halle
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Country [5]
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Germany
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State/province [5]
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Tubingen
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Country [6]
0
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United Kingdom
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State/province [6]
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Cambridge
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Country [7]
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United Kingdom
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State/province [7]
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Hampshire
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Country [8]
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United Kingdom
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State/province [8]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ethicon, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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)
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Trial website
https://clinicaltrials.gov/study/NCT00521066
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Trial related presentations / publications
Zyczynski HM, Carey MP, Smith AR, Gauld JM, Robinson D, Sikirica V, Reisenauer C, Slack M; Prosima Study Investigators. One-year clinical outcomes after prolapse surgery with nonanchored mesh and vaginal support device. Am J Obstet Gynecol. 2010 Dec;203(6):587.e1-8. doi: 10.1016/j.ajog.2010.08.001. Sayer T, Lim J, Gauld JM, Hinoul P, Jones P, Franco N, Van Drie D, Slack M; Prosima Study Investigators. Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device. Int Urogynecol J. 2012 Apr;23(4):487-93. doi: 10.1007/s00192-011-1600-3. Epub 2011 Dec 6.
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Public notes
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Contacts
Principal investigator
Name
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David Robinson, M.D.
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Address
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Ethicon, Inc.
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Country
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Phone
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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Address
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0
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Zyczynski HM, Carey MP, Smith AR, Gauld JM, Robins...
[
More Details
]
Journal
Sayer T, Lim J, Gauld JM, Hinoul P, Jones P, Franc...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00521066
Download to PDF