Clinical trial NCT04829058: GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Official title: A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Keywords: GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
POP
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 100
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 baseline diagnosis of apical vaginal or uterine prolapse;
* who had laparotomic or laparoscopic sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse within 7 years of enrolment;
* where GYNEMESH PS Mesh was used as a bridging material, and;
* who are willing and able to participate in prospective follow-up.

Brief summary: The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.


Eligibility criteria: Inclusion Criteria:

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

1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
2. GYNEMESH PS Mesh was used as a bridging material according to the IFU.
3. Able and willing to participate in follow-up
4. 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. Subjects \< 21 years of age at the time of informed consent
2. Subjects who had transvaginal approach for surgery
3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Primary outcomes:
measure: Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange
timeFrame: Post-surgery through study completion, approximately 7 yrs
Secondary outcomes:
measure: Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire
timeFrame: Post-surgery through study completion, approximately 7yrs
measure: Pelvic Floor Distress Inventory (PFDI-20) Questionnaire
timeFrame: Post-surgery through study completion, approximately 7yrs
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) or Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
timeFrame: Post-surgery through study completion, approximately 7yrs
Other outcomes:
Locations:
city: North Wales
country: United States
facility: Institute for Female Pelvic Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UMPC
state: Pennsylvania
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
Study officials:
affiliation: Ethicon, Inc.
name: Martin Weisberg, MD
role: STUDY_DIRECTOR
References: