What this study is
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.
What's being tested
- Intervention
Intervention · DEVICE
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.
Study details
- Official title
- 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
- Sponsor
- Ethicon, Inc.
- Conditions
- Stress Urinary Incontinence · Pelvic Organ Prolapse
- Enrolling
- 1,000 people
- Starts
- 2022-04-11
- Est. completion
- 2038-03-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (10)
9 openYale University
New Haven, Connecticut, United States
RecruitingDuke University
Durham, North Carolina, United States
RecruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RecruitingUPMC
Pittsburgh, Pennsylvania, United States
Recruiting
6 sites outside the US
Krankenhaus der barmherzigen Schwestern
Linz, Austria
RecruitingHerlev Hospital
Hillerød, Denmark
Not yet recruitingHopital Jeanne de Flandres
Lille, France
Not yet recruitingBio-Medical University Rome
Rome, Italy
RecruitingKarolinska Institute
Stockholm, Sweden
RecruitingUniversitatsklinikum Tubingen
Tübingen, Germany
Active, not recruiting
Study team
Sponsor
Ethicon, Inc.
Study ID ESC_2020_03
Study director
Martin Weisberg, MD
Ethicon, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.