Clinical trial NCT04829175: Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress Urinary Incontinence
Pelvic Organ Prolapse
Keywords: Stress Urinary Incontinence
Pelvic Organ Prolapse
SUI
POP
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 for SUI and POP.


Eligibility criteria: Inclusion Criteria:

Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry:

SUI

1. Stress urinary incontinence symptoms
2. Urodynamic stress incontinence confirmed with urodynamic testing
3. Female patient ≥ 21 years of age
4. Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling
5. Planned surgery for primary SUI
6. Patient able and willing to participate in follow-up
7. 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

Exclusion Criteria

Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry:

1. 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
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products
3. History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP)
4. Pregnancy or plans for future pregnancy
5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice
6. Current genitourinary fistula or urethral diverticulum
7. Reversible cause of incontinence (i.e. drug effect) for SUI only
8. Severe vaginal atrophy
9. History of pelvic irradiation therapy
10. Contraindication to surgery

Primary outcomes:
measure: Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change
timeFrame: Post-surgery through registry completion, approximately 5-10 yrs
measure: Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change
timeFrame: Post-surgery through registry completion, approximately 5-10 yrs
Secondary outcomes:
measure: SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: Baseline and post-surgery through registry completion, approximately 10 yrs
measure: SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
timeFrame: Baseline and post-surgery through registry completion, approximately 10 yrs
measure: SUI: Patient Global Impression of Improvement questionnaire (PGI-I)
timeFrame: Post-surgery through registry completion, approximately 10 yrs
measure: SUI: Wong-Baker FACES Pain Rating Scale
timeFrame: Post-surgery through registry completion, approximately 10 yrs
measure: POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire
timeFrame: Baseline and post-surgery through registry completion, approximately 10 yrs
measure: POP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
timeFrame: Baseline and post-surgery through registry completion, approximately 10 yrs
measure: POP: Patient Global Impression of Improvement questionnaire (PGI-I)
timeFrame: Post-surgery through registry completion, approximately 10 yrs
measure: POP: Wong-Baker FACES Pain Rating Scale
timeFrame: Post-surgery through registry completion, approximately 10 yrs
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Linz
country: Austria
facility: Krankenhaus der barmherzigen Schwestern
city: Hillerod
country: Denmark
facility: Herlev Hospital
city: Lille
country: France
facility: Hopital Jeanne de Flandres
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Rome
country: Italy
facility: Bio-Medical University Rome
city: Warsaw
country: Poland
facility: Żelazna Medical Center
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Ethicon, Inc.
name: Martin Weisberg, MD
role: STUDY_DIRECTOR
References: