Clinical trial NCT04829357: Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Official title: A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT ABBREVO® Continence System for the Treatment of Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress Urinary Incontinence
Keywords: Gynecare TVT ABBREVO® Continence System
SUI
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 195
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility criteria: Inclusion Criteria:

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

1. Stress urinary incontinence symptoms
2. Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
3. Female subjects ≥ 21 years of age requiring treatment of SUI
4. Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
5. Planned surgery for primary stress incontinence without concomitant prolapse surgery
6. Patient able and willing to participate in follow-up
7. Subject or authorized representative has signed the approved informed consent

Exclusion Criteria

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

1. 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
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
3. History of previous synthetic, biologic or fascial sub-urethral sling
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)
8. Contraindication to surgery

Primary outcomes:
measure: Cough Stress Test (CST) Assessment Change
timeFrame: Post-surgery through study completion, approximately 5-10 yrs
Secondary outcomes:
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: Post-surgery through study completion, approximately 10 yrs
measure: International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: Baseline and post-surgery through study completion, approximately 10 yrs
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
timeFrame: Baseline and post-surgery through study completion, approximately 10 yrs
measure: Wong-Baker FACES® Pain Rating Scale
timeFrame: Post-surgery through study completion, approximately 10 yrs
Other outcomes:
Locations:
city: North Wales
country: United States
facility: Institute for Female Pelvic Medicine
state: Pennsylvania
city: Rome
country: Italy
facility: Bio-Medical University Rome
city: Rome
country: Italy
facility: Ospedale San Pietro Fatebenefratelli
city: Warsaw
country: Poland
facility: Zelazna Medical Center
city: Mendrisio
country: Switzerland
facility: Ospedale Regionale Beata Vergine
Study officials:
affiliation: Ethicon, Inc.
name: Martin Weisberg, MD
role: STUDY_DIRECTOR
References: