Stress Urinary IncontinenceNCT04829175
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
An observational study of Stress Urinary Incontinence and Pelvic Organ Prolapse, run by Ethicon, Inc. at 10 sites in 7 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Pelvic Organ Prolapse
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 11 Apr 2022to 31 Mar 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients ≥ 21 years of age with: * A diagnosis of SUI, resulting from urethral hypermobility and/or intrinsic sphincter deficiency AND/OR * A diagnosis of vaginal vault or uterine prolapses where surgical treatment (sacrocolposuspension or sacrocolpopexy, laparotomic or laparoscopic approach including robotic assisted) is warranted AND * Are scheduled to have surgical treatment using an Ethicon Gynecare Pelvic Mesh Product
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 7 countries
United States4 sites, 4 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27707
- Recruiting
Yale University
New Haven, Connecticut, 06510
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
UPMC
Pittsburgh, Pennsylvania, 15213
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus der barmherzigen Schwestern
Linz
About this study
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
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.
- Conditions
- Stress Urinary Incontinence, Pelvic Organ Prolapse
- Being tested
- Intervention
- Keywords
- Stress Urinary Incontinence, Pelvic Organ Prolapse, SUI, POP
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Post-surgery through registry completion, approximately 5-10 yrs
Secondary outcomes (8)
SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Measured: Baseline and post-surgery through registry completion, approximately 10 yrs
SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Measured: Baseline and post-surgery through registry completion, approximately 10 yrs
SUI: Patient Global Impression of Improvement questionnaire (PGI-I)
Measured: 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
Measured: Post-surgery through registry completion, approximately 10 yrs
POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire
Measured: Baseline and post-surgery through registry completion, approximately 10 yrs
POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Measured: Baseline and post-surgery through registry completion, approximately 10 yrs
POP: Patient Global Impression of Improvement questionnaire (PGI-I)
Measured: 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)
Measured: Post-surgery through registry completion, approximately 10 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start11 Apr 2022
- Primary completion31 Mar 2033 (estimated)
- Study completion31 Mar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Weisberg, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829175
- Sponsor's protocol ID
- ESC_2020_03
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04829175
- Acronym / sponsor ID
- ESC_2020_03
- Conditions
- Stress Urinary Incontinence, Pelvic Organ Prolapse
- Keywords
- Stress Urinary Incontinence, Pelvic Organ Prolapse, SUI, POP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 31 Mar 2033 (estimated)
- Study completion
- 31 Mar 2038 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients ≥ 21 years of age with: * A diagnosis of SUI, resulting from urethral hypermobility and/or intrinsic sphincter deficiency AND/OR * A diagnosis of vaginal vault or uterine prolapses where surgical treatment (sacrocolposuspension or sacrocolpopexy, laparotomic or laparoscopic approach including robotic assisted) is warranted AND * Are scheduled to have surgical treatment using an Ethicon Gynecare Pelvic Mesh Product
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThere 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. | Device | – |
Primary outcome
Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change
Time frame: Post-surgery through registry completion, approximately 5-10 yrs
Objective cure (success) approximately 5-10 years after surgery, defined as a negative standardized cough stress test (CST)
Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change
Time frame: Post-surgery through registry completion, approximately 5-10 yrs
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
8 secondary outcomes
SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline and post-surgery through registry completion, approximately 10 yrs
SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: Baseline and post-surgery through registry completion, approximately 10 yrs
SUI: Patient Global Impression of Improvement questionnaire (PGI-I)
Time frame: Post-surgery through registry completion, approximately 10 yrs
SUI: Wong-Baker FACES Pain Rating Scale
Time frame: Post-surgery through registry completion, approximately 10 yrs
POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire
Time frame: Baseline and post-surgery through registry completion, approximately 10 yrs
POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: Baseline and post-surgery through registry completion, approximately 10 yrs
POP: Patient Global Impression of Improvement questionnaire (PGI-I)
Time frame: Post-surgery through registry completion, approximately 10 yrs
POP: Wong-Baker FACES Pain Rating Scale
Time frame: Post-surgery through registry completion, approximately 10 yrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Weisberg, MD study director
Ethicon, Inc.
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence and Pelvic Organ Prolapse, run by Ethicon, Inc. at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Austria, Denmark, France, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Romanowski (908-808-6219, cromanow@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change (time frame: Post-surgery through registry completion, approximately 5-10 yrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.