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.
Study Type
OBSERVATIONAL
Enrollment
1,000
There is no intervention, beyond necessary clinical care, in this registry. The surgical procedures being performed within the registry are identical to the surgical procedures patients would receive as part of SOC.
Yale University
New Haven, Connecticut, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGUniversity of Pennsylvania
Stress Urinary Incontinence(SUI)- Cough Stress Test(CST) Assessment Change
Objective cure (success) approximately 5-10 years after surgery, defined as a negative standardized cough stress test (CST)
Time frame: Post-surgery through registry completion, approximately 5-10 yrs
Pelvic Organ Prolapse (POP)- Physical Examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment Change
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
Time frame: Post-surgery through registry completion, approximately 5-10 yrs
SUI: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline and post-surgery through registry completion, approximately 10 yrs
SUI: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: Baseline and post-surgery through registry completion, approximately 10 yrs
SUI: Patient Global Impression of Improvement questionnaire (PGI-I)
Time frame: Post-surgery through registry completion, approximately 10 yrs
SUI: Wong-Baker FACES Pain Rating Scale
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure
Time frame: Post-surgery through registry completion, approximately 10 yrs
POP: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire
Time frame: Baseline and post-surgery through registry completion, approximately 10 yrs
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Philadelphia, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
RECRUITINGKrankenhaus der barmherzigen Schwestern
Linz, Austria
RECRUITINGHerlev Hospital
Hillerød, Denmark
NOT_YET_RECRUITINGHopital Jeanne de Flandres
Lille, France
NOT_YET_RECRUITINGUniversitatsklinikum Tubingen
Tübingen, Germany
RECRUITINGBio-Medical University Rome
Rome, Italy
RECRUITINGKarolinska Institute
Stockholm, Sweden
RECRUITINGPOP: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Time frame: Baseline and post-surgery through registry completion, approximately 10 yrs
POP: Patient Global Impression of Improvement questionnaire (PGI-I)
Time frame: Post-surgery through registry completion, approximately 10 yrs
POP: Wong-Baker FACES Pain Rating Scale
To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to registry device or procedure (if applicable)
Time frame: Post-surgery through registry completion, approximately 10 yrs