Health TrialsbyHealthPanel

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

ConditionsStress Urinary IncontinencePelvic Organ Prolapse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorEthicon, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)

Time frame
Baseline and post-surgery through registry completion, approximately 10 yrs
3

SUI: Patient Global Impression of Improvement questionnaire (PGI-I)

Time frame
Post-surgery through registry completion, approximately 10 yrs
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ethicon, Inc.

Lead sponsor

Source ClinicalTrials.gov
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