Health TrialsbyHealthPanel

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

ConditionPelvic Organ Prolapse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorEthicon, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

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.

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ethicon, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now