An observational study in Stress Urinary Incontinence and Pelvic Organ Prolapse, sponsored by Ethicon, Inc.. Recruiting at 10 sites in 7 countries. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Ethicon, Inc. (part of Johnson & Johnson) · Observational
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 130 across 127 observational studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female patients ≥ 21 years of age with:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
Time frame: 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
Time frame: Post-surgery through registry completion, approximately 5-10 yrs
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
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure
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
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure (if applicable)
Time frame: Post-surgery through registry completion, approximately 10 yrs
Not enrolling at this site.
Plan to share: 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.
Data sharing details ↗ · yoda.yale.edu
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Mar 2033, 131 months after the start.
Of 48 observational studies under Urinary Incontinence, Stress, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 107. This study's planned 131 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Urinary Incontinence, Stress →