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NCT Number: NCT04829058

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Universitatsklinikum Tubingen, Tübingen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
  • GYNEMESH PS Mesh was used as a bridging material according to the IFU.
  • Able and willing to participate in follow-up
  • 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:

  • Subjects < 21 years of age at the time of informed consent
  • Subjects who had transvaginal approach for surgery
  • Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Treatment and study plan

Intervention

Device

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

Primary outcomes

  1. Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange

    Time frame: Post-surgery through study completion, approximately 7 yrs

    Objective cure of vaginal or uterine prolapse approximately 7 years after surgery, defined as POP-Q stage ≤2 at point C as determined with physical exam.

Secondary outcomes

  1. Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire

    Time frame: Post-surgery through study completion, approximately 7yrs

  2. Pelvic Floor Distress Inventory (PFDI-20) Questionnaire

    Time frame: Post-surgery through study completion, approximately 7yrs

  3. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) or Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)

    Time frame: Post-surgery through study completion, approximately 7yrs

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Romanowski

CONTACT

[email protected]

908-808-6219

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Official study title

A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh

Important dates

Study start
2021
Primary completion
2031
Study completion
2032
First posted
Apr 2, 2021
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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