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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:
SUI
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:
Female patients ≥ 21 years of age
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Female patients ≥ 21 years of age with:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Romanowski | Contact | 908-808-6219 | cromanow@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Martin Weisberg, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States | |
| Duke University |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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 |
| Recruiting |
| Durham |
| North Carolina |
| 27707 |
| United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Krankenhaus der barmherzigen Schwestern | Recruiting | Linz | Austria |
| Herlev Hospital | Not yet recruiting | Hillerød | Denmark |
| Hopital Jeanne de Flandres | Not yet recruiting | Lille | France |
| Universitatsklinikum Tubingen | Active, not recruiting | Tübingen | Germany |
| Bio-Medical University Rome | Recruiting | Rome | Italy |
| Karolinska Institute | Recruiting | Stockholm | Sweden |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |