Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Study Overview
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Brief Summary
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The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.

Official Title
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A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

Conditions
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Stress Urinary Incontinence, Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry: SUI Stress urinary incontinence symptoms Urodynamic stress incontinence confirmed with urodynamic testing Female patient ≥ 21 years of age Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling Planned surgery for primary SUI Patient able and willing to participate in follow-up Patient or authorized representative has signed the approved Informed consent POP 1. Uterine or vaginal vault prolapse symptoms 2. Urodynamic testing (optional) 3. Female patient ≥ 21 years of age 4. Desired surgical correction of POP using synthetic mesh 5. Planned surgery for uterine or vaginal vault prolapse with or without concomitant SUI surgery 6. Patient able and willing to participate in follow-up 7. Patient or authorized representative has signed the approved Informed consent Exclusion Criteria Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry: Physical or psychological condition which would impair registry participation or are unwilling or unable to participate in all required registry visits and are unable to complete the questionnaires Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP) Pregnancy or plans for future pregnancy History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice Current genitourinary fistula or urethral diverticulum Reversible cause of incontinence (i.e. drug effect) for SUI only Severe vaginal atrophy History of pelvic irradiation therapy Contraindication to surgery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intervention|There is no intervention, beyond necessary clinical care, in this registry. The surgical procedures being performed within the registry are identical to the surgical procedures patients would receive as part of SOC.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change | Objective cure (success) approximately 5-10 years after surgery, defined as a negative standardized cough stress test (CST) | Post-surgery through registry completion, approximately 5-10 yrs | 
| Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change | Objective cure (success) approximately 5-10 years after surgery, defined as the absence of prolapse beyond the hymen as determined by a physical examination with POP-Q | Post-surgery through registry completion, approximately 5-10 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) |  | Baseline and post-surgery through registry completion, approximately 10 yrs | 
| SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) |  | Baseline and post-surgery through registry completion, approximately 10 yrs | 
| SUI: Patient Global Impression of Improvement questionnaire (PGI-I) |  | Post-surgery through registry completion, approximately 10 yrs | 
| SUI: Wong-Baker FACES Pain Rating Scale | To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure | Post-surgery through registry completion, approximately 10 yrs | 
| POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire |  | Baseline and post-surgery through registry completion, approximately 10 yrs | 
| POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) |  | Baseline and post-surgery through registry completion, approximately 10 yrs | 
| POP: Patient Global Impression of Improvement questionnaire (PGI-I) |  | Post-surgery through registry completion, approximately 10 yrs | 
| POP: Wong-Baker FACES Pain Rating Scale | To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure (if applicable) | Post-surgery through registry completion, approximately 10 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Urinary Incontinence, Pelvic Organ Prolapse, SUI, POP