GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse

Ethicon, Inc.150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Pelvic Organ Prolapse

Interventions

GYNECARE PROSIMA* Pelvic Floor Repair SystemDEVICE

procedure for pelvic organ prolapse

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Specialists in Urology

Naples, Florida, United States

Female Pelvic Medicine and Urogynecology Institute of Michigan

Dearborn, Michigan, United States

Female Pelvic Medicine & Urogynecology

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 12-months

Secondary Outcomes

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

Time frame: 24 months

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.

Time frame: 12 months

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.

Time frame: 24 months

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)

Time frame: 12 months

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)

Time frame: 24 months

Mean PFDI-20 score

Time frame: 12 months

Data from ClinicalTrials.gov

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The Institute for Female Pelvic Medicine & Reconstructive Surgery

Allentown, Pennsylvania, United States

Magee Women's Hospital of the Universtiy of Pittsburgh

Pittsburgh, Pennsylvania, United States

Royal Women's Hospital

Melbourne, Australia

Bereich Urogynakologie

Halle, Germany

Universitatsklinik Tubingen

Tübingen, Germany

Addenbrookes Hospital

Cambridge, United Kingdom

North Hampshire Hospital

Hampshire, United Kingdom

...and 1 more locations

Time frame: 24 months

Mean change from baseline in PFDI-20 scores

Time frame: 24 months

Mean change from baseline in PFDI-20 scores

Time frame: 12 months

Mean POPDI score

POPDI is a sub score of PFDI-20

Time frame: 12 months

Mean POPDI score

POPDI is a sub score of PFDI-20

Time frame: 24 months

Mean change from baseline in POPDI score

POPDI is a sub scores of PFDI-20

Time frame: 12 months

Mean change from baseline in POPDI score

POPDI is a sub score of PFDI-20

Time frame: 24 months

Mean CRADI score

CRADI is a sub score of PFDI-20

Time frame: 12 months

Mean CRADI score

CRADI is a sub score of PFDI-20

Time frame: 24 months

Mean change from baseline in CRADI score

CRADI is a sub score of PFDI-20

Time frame: 12 months

Mean change from baseline in CRADI score

CRADI is a sub score of PFDI-20

Time frame: 24 months

Mean UDI score

UDI is a sub score of PFDI-20

Time frame: 12 months

Mean UDI score

UDI is a sub score of PFDI-20

Time frame: 24 months

Mean change from baseline in UDI score

UDI is a sub score of PFDI-20

Time frame: 12 months

Mean change from baseline in UDI score

UDI is a sub score of PFDI-20

Time frame: 24 months

EuroQol (EQ-5D health state) change from baseline

Time frame: 12 months

EuroQol (EQ-5D health state) change from baseline

Time frame: 24 months

Mean PFIQ-7 score

Time frame: 12 months

Mean PFIQ-7 score

Time frame: 24 months

Mean change from baseline in PFIQ-7 score

Time frame: 12 months

Mean change from baseline in PFIQ-7 score

Time frame: 24 months

Mean POPIQ score

POPIQ is a sub-score of PFIQ-7

Time frame: 12 months

Mean POPIQ score

POPIQ is a sub-score of PFIQ-7

Time frame: 24 months

Mean change from baseline in POPIQ score

POPIQ is a sub-score of PFIQ-7

Time frame: 12 months

Mean change from baseline in POPIQ score

POPIQ is a sub-score of PFIQ-7

Time frame: 24 months

Mean CRAIQ score

CRAIQ is a sub-score of PFIQ-7

Time frame: 12 months

Mean CRAIQ score

CRAIQ is a sub-score of PFIQ-7

Time frame: 24 months

Mean change from baseline in CRAIQ score

CRAIQ is a sub-score of PFIQ-7

Time frame: 12 months

Mean change from baseline in CRAIQ score

CRAIQ is a sub-score of PFIQ-7

Time frame: 24 months

Mean UIQ score

UIQ is a sub-score of PFIQ-7

Time frame: 12 months

Mean UIQ score

UIQ is a sub-score of PFIQ-7

Time frame: 24 months

Mean change from baseline in UIQ score

UIQ is a sub-score of PFIQ-7

Time frame: 12 months

Mean change from baseline in UIQ score

UIQ is a sub-score of PFIQ-7

Time frame: 24 months

Mean PISQ-12 score

In subjects sexually active at baseline, assessment of sexual function

Time frame: 12 months

Mean PISQ-12 score

In subjects sexually active at baseline, assessment of sexual function

Time frame: 24 months

Mean change from baseline in PISQ-12 score

In subjects sexually active at baseline, assessment of sexual function

Time frame: 12 months

Mean change from baseline in PISQ-12 score

In subjects sexually active at baseline, assessment of sexual function

Time frame: 24 months

Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia

Time frame: ongoing

Length of procedure

From time to first incision to time of last suture used to secure VSD

Time frame: perioperative

Pain score measured using Visual Analog Scale (VAS).

Time frame: 24 hours post surgery and at the 3-4 week visit

Discomfort of balloon removal, measured using VAS at time of removal.

Time frame: 24 hrs post-surgical

Subject perception of VSD: Awareness

Measured by visual analogue scale

Time frame: 3-4 week visit

Subject perception of VSD: Discomfort

Measured by visual analogue scale

Time frame: 3-4 week visit

Subject perception of VSD: Acceptability of discharge

Measured by visual analogue scale

Time frame: 3-4 week visit

Subject global impression

assessed on a 5 point Likert scale

Time frame: 12 month visit

Subject global impression

assessed on a 5 point Likert scale

Time frame: 24 month visit