Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry

Recruiting

• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence

• Registration Number: NCT04829175
• Lead Sponsor: Ethicon, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2022-04-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2036-03-30
• Study Completion: 2036-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

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

8. 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change	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	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

Secondary Outcome Measures

Name	Time	Method
POP: Patient Global Impression of Improvement questionnaire (PGI-I)	Post-surgery through registry completion, approximately 10 yrs
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)	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	Post-surgery through registry completion, approximately 10 yrs	To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure
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: Wong-Baker FACES Pain Rating Scale	Post-surgery through registry completion, approximately 10 yrs	To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure (if applicable)

Trial Locations

Locations (11)

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Hopital Jeanne de Flandres; 🇫🇷 Lille, France

Universitatsklinikum Tubingen; 🇩🇪 Tubingen, Germany

Karolinska Institute; 🇸🇪 Stockholm, Sweden

Krankenhaus der barmherzigen Schwestern; 🇦🇹 Linz, Austria

Żelazna Medical Center; 🇵🇱 Warsaw, Poland

Yale University; 🇺🇸 New Haven, Connecticut, United States

Herlev Hospital; 🇩🇰 Hillerod, Denmark

Bio-Medical University Rome; 🇮🇹 Rome, Italy