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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
300-06-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Success based on overall POP-Q score at 12 months post-procedure. - Success is determined by achievement of an overall POP-Q score of ICS Stage =1, without further re-intervention for POP.
Timepoint [1] 0 0
12-months
Secondary outcome [1] 0 0
Success based on overall POP-Q score at 24 months post-procedure. - Success is determined by achievement of an overall POP-Q score of ICS Stage =1, without further re-intervention for POP
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Success based on treated compartment ICS POP-Q stage - Success will be determined by achievement of treated compartment POP-Q score of ICS Stage =1, without further re-intervention for POP.
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Success based on treated compartment ICS POP-Q stage - Success will be determined by achievement of treated compartment POP-Q score of ICS Stage =1, without further re-intervention for POP.
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Success defined as the leading edge within the hymen - 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)
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Success defined as the leading edge within the hymen - 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)
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Mean PFDI-20 score
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Mean PFDI-20 score
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Mean change from baseline in PFDI-20 scores
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Mean change from baseline in PFDI-20 scores
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Mean POPDI score - POPDI is a sub score of PFDI-20
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Mean POPDI score - POPDI is a sub score of PFDI-20
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
Mean change from baseline in POPDI score - POPDI is a sub scores of PFDI-20
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Mean change from baseline in POPDI score - POPDI is a sub score of PFDI-20
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Mean CRADI score - CRADI is a sub score of PFDI-20
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
Mean CRADI score - CRADI is a sub score of PFDI-20
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
Mean change from baseline in CRADI score - CRADI is a sub score of PFDI-20
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Mean change from baseline in CRADI score - CRADI is a sub score of PFDI-20
Timepoint [17] 0 0
24 months
Secondary outcome [18] 0 0
Mean UDI score - UDI is a sub score of PFDI-20
Timepoint [18] 0 0
12 months
Secondary outcome [19] 0 0
Mean UDI score - UDI is a sub score of PFDI-20
Timepoint [19] 0 0
24 months
Secondary outcome [20] 0 0
Mean change from baseline in UDI score - UDI is a sub score of PFDI-20
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Mean change from baseline in UDI score - UDI is a sub score of PFDI-20
Timepoint [21] 0 0
24 months
Secondary outcome [22] 0 0
EuroQol (EQ-5D health state) change from baseline
Timepoint [22] 0 0
12 months
Secondary outcome [23] 0 0
EuroQol (EQ-5D health state) change from baseline
Timepoint [23] 0 0
24 months
Secondary outcome [24] 0 0
Mean PFIQ-7 score
Timepoint [24] 0 0
12 months
Secondary outcome [25] 0 0
Mean PFIQ-7 score
Timepoint [25] 0 0
24 months
Secondary outcome [26] 0 0
Mean change from baseline in PFIQ-7 score
Timepoint [26] 0 0
12 months
Secondary outcome [27] 0 0
Mean change from baseline in PFIQ-7 score
Timepoint [27] 0 0
24 months
Secondary outcome [28] 0 0
Mean POPIQ score - POPIQ is a sub-score of PFIQ-7
Timepoint [28] 0 0
12 months
Secondary outcome [29] 0 0
Mean POPIQ score - POPIQ is a sub-score of PFIQ-7
Timepoint [29] 0 0
24 months
Secondary outcome [30] 0 0
Mean change from baseline in POPIQ score - POPIQ is a sub-score of PFIQ-7
Timepoint [30] 0 0
12 months
Secondary outcome [31] 0 0
Mean change from baseline in POPIQ score - POPIQ is a sub-score of PFIQ-7
Timepoint [31] 0 0
24 months
Secondary outcome [32] 0 0
Mean CRAIQ score - CRAIQ is a sub-score of PFIQ-7
Timepoint [32] 0 0
12 months
Secondary outcome [33] 0 0
Mean CRAIQ score - CRAIQ is a sub-score of PFIQ-7
Timepoint [33] 0 0
24 months
Secondary outcome [34] 0 0
Mean change from baseline in CRAIQ score - CRAIQ is a sub-score of PFIQ-7
Timepoint [34] 0 0
12 months
Secondary outcome [35] 0 0
Mean change from baseline in CRAIQ score - CRAIQ is a sub-score of PFIQ-7
Timepoint [35] 0 0
24 months
Secondary outcome [36] 0 0
Mean UIQ score - UIQ is a sub-score of PFIQ-7
Timepoint [36] 0 0
12 months
Secondary outcome [37] 0 0
Mean UIQ score - UIQ is a sub-score of PFIQ-7
Timepoint [37] 0 0
24 months
Secondary outcome [38] 0 0
Mean change from baseline in UIQ score - UIQ is a sub-score of PFIQ-7
Timepoint [38] 0 0
12 months
Secondary outcome [39] 0 0
Mean change from baseline in UIQ score - UIQ is a sub-score of PFIQ-7
Timepoint [39] 0 0
24 months
Secondary outcome [40] 0 0
Mean PISQ-12 score - In subjects sexually active at baseline, assessment of sexual function
Timepoint [40] 0 0
12 months
Secondary outcome [41] 0 0
Mean PISQ-12 score - In subjects sexually active at baseline, assessment of sexual function
Timepoint [41] 0 0
24 months
Secondary outcome [42] 0 0
Mean change from baseline in PISQ-12 score - In subjects sexually active at baseline, assessment of sexual function
Timepoint [42] 0 0
12 months
Secondary outcome [43] 0 0
Mean change from baseline in PISQ-12 score - In subjects sexually active at baseline, assessment of sexual function
Timepoint [43] 0 0
24 months
Secondary outcome [44] 0 0
Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia
Timepoint [44] 0 0
ongoing
Secondary outcome [45] 0 0
Length of procedure - From time to first incision to time of last suture used to secure VSD
Timepoint [45] 0 0
perioperative
Secondary outcome [46] 0 0
Pain score measured using Visual Analog Scale (VAS).
Timepoint [46] 0 0
24 hours post surgery and at the 3-4 week visit
Secondary outcome [47] 0 0
Discomfort of balloon removal, measured using VAS at time of removal.
Timepoint [47] 0 0
24 hrs post-surgical
Secondary outcome [48] 0 0
Subject perception of VSD: Awareness - Measured by visual analogue scale
Timepoint [48] 0 0
3-4 week visit
Secondary outcome [49] 0 0
Subject perception of VSD: Discomfort - Measured by visual analogue scale
Timepoint [49] 0 0
3-4 week visit
Secondary outcome [50] 0 0
Subject perception of VSD: Acceptability of discharge - Measured by visual analogue scale
Timepoint [50] 0 0
3-4 week visit
Secondary outcome [51] 0 0
Subject global impression - assessed on a 5 point Likert scale
Timepoint [51] 0 0
12 month visit
Secondary outcome [52] 0 0
Subject global impression - assessed on a 5 point Likert scale
Timepoint [52] 0 0
24 month visit

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Women's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Germany
State/province [4] 0 0
Halle
Country [5] 0 0
Germany
State/province [5] 0 0
Tubingen
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Cambridge
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Hampshire
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ethicon, Inc.
Address
Country

Ethics approval
Ethics application status

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)
Trial website
https://clinicaltrials.gov/show/NCT00521066
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Robinson, M.D.
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications