Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

NCT04829357 | Recruiting FDA Device

• 1 other identifier: ESC_2020_04
• Study Type: observational
• Target: 195
• Locations: 3 countries
• Sites: 4

Brief Summary

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

Conditions

Stress Urinary Incontinence

Keywords

Gynecare TVT ABBREVO® Continence System; SUI

Outcome Measures

Primary Outcomes (1)

• Cough Stress Test (CST) Assessment Change

  Objective cure of Stress Urinary Incontinence (SUI) (treatment success) approximately 5-10 years after surgery, defined as a negative CST

  Post-surgery through study completion, approximately 5-10 yrs

Secondary Outcomes (4)

• Patient Global Impression of Improvement (PGI-I)

  Post-surgery through study completion, approximately 10 yrs

• International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)

  Baseline and post-surgery through study completion, approximately 10 yrs

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

  Baseline and post-surgery through study completion, approximately 10 yrs

• Wong-Baker FACES® Pain Rating Scale

  Post-surgery through study completion, approximately 10 yrs

Interventions

Intervention DEVICE

There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures the subjects would receive as part of SOC.

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female subjects ≥ 21 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects ≥ 21 years of age with a diagnosis of SUI, resulting from urethral hypermobility and/or intrinsic sphincter deficiency

You may qualify if:

• Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
• Stress urinary incontinence symptoms
• Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
• Female subjects ≥ 21 years of age requiring treatment of SUI
• Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
• Planned surgery for primary stress incontinence without concomitant prolapse surgery
• Patient able and willing to participate in follow-up
• Subject or authorized representative has signed the approved informed consent

You may not qualify if:

• Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
• Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study 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 study product
• History of previous synthetic, biologic or fascial sub-urethral sling
• 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.
• Current genitourinary fistula or urethral diverticulum
• Reversible cause of incontinence (i.e. drug effect)
• Contraindication to surgery

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (4)

Institute for Female Pelvic Medicine

North Wales, Pennsylvania, 19454, United States

RECRUITING

Bio-Medical University Rome

Rome, Italy

RECRUITING

Ospedale San Pietro Fatebenefratelli

Rome, Italy

RECRUITING

Ospedale Regionale Beata Vergine

Mendrisio, Switzerland

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Methods

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Martin Weisberg, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Central Study Contacts

Christine Romanowski

CONTACT

908-808-6219; cromanow@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: April 2, 2021
• Study Start: September 9, 2021
• Primary Completion (Estimated): September 30, 2036
• Study Completion (Estimated): February 27, 2037
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1); CH (1); IT (2)