Clinical trial NCT04829994: Post-Market Clinical Follow-Up onTVT EXACT® Continence System
Official title: A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress Urinary Incontinence
Keywords: GYNECARE TVT EXACT® 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 utrethral 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 EXACT® Continence System in women undergoing retropubic 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. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test
3. Female subjects ≥ 21 years of age requiring treatment of SUI
4. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling
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 pubo-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, approximately 10 yrs completion
measure: Wong-Baker FACES® Pain Rating Scale
timeFrame: Post-surgery through study completion, approximately 10 yrs
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: North Wales
country: United States
facility: Institute for Female Pelvic Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Linz
country: Austria
facility: Ordensklinikum Linz
city: Hillerod
country: Denmark
facility: Herlev Hospital
city: Lille
country: France
facility: Hopital Jeanne de Flandres
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Ethicon, Inc.
name: Martin Weisberg, MD
role: STUDY_DIRECTOR
References: