Retrospective Data Analysis PelviGYNious/EndoGYNious

Retrospective Data Analysis PelviGYNious/EndoGYNious (PMCF-4.2-004)

The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.

Study Overview

• Status: Active, not recruiting
• Conditions: Prolapse; Pelvic Organ Prolapse (POP); Sacrocolpopexy
• Intervention / Treatment: Device: EndoGYNious; Device: PelviGYNious

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany
    • Universitätsklinikum Erlangen, Frauenklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The planned clinical investigation is a retrospective chart review of clinical data.

All patients who underwent surgery between January 2016 and December 2023 and met the inclusion criteria and no exclusion criteria were analyzed.

Description

Inclusion Criteria:

• Surgery for POP
• Implantation of either EndoGYNious or PelviGYNious
• Concomitant procedures are allowed
• Women minimum 18 years old
• Written informed consent for surgery

Exclusion Criteria:

Patients who rule out subsequent contact by the hospital will be excluded.

The use of the products is contraindicated in case of:

• pregnancy and/or patients who consider future pregnancies
• adolescent/ pubescent patients
• existence of a known sensitivity/ allergy against plastic materials such as polypropylene, polyester, etc.
• any pathology, including known or suspected uterine pathology, which would compromise placement of the implant/mesh (e.g. anatomical distortion or abnormalities)
• known anticoagulation disorder
• anticoagulant therapy
• autoimmune connective tissue disease
• renal insufficiency and upper urinary tract obstruction
• cancer illnesses of the vagina / cervix / rectum
• undergone radiation therapy on the vagina, cervix, rectum
• planned or emergency opening of the gastro-intestinal tract, as this could cause a risk of product contamination that could lead to infection that would require removal of the implant/device
• active or latent infection especially of the genital system and/or urinary tract

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EndoGYNious; Patient received EndoGYNious mesh implant.	Device: EndoGYNious; Patient received EndoGYNious implant.
PelviGYNious; Patient received PelviGYNious mesh implant.	Device: PelviGYNious; Patient received PelviGYNious implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient subjective outcome	Patient subjective outcome after POP treatment with EndoGYNious or PelviGYNious will be measured with a validated questionnaire (German Pelvic Floor Questionnaire "Deutscher Beckenboden-Fragebogen") . This questionnaire focus on 4 items (bladder, bowel, prolapse, sexuality). Each item has its scores, scores were summed up for each category (bladder max. 45, bowel max. 34, prolapse max. 15, sexual max. 21), Calculation: (achieved value of category/ max. value of category)*10; max. value 10 for each category, max. final score 40 The postoperative scores will be compared with the preoperative scores.	From baseline to the end of last follow-up [3 months, 12 months]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	To analyze postoperative complications in women undergoing POP treatment with EndoGYNious or PelviGYNious during the follow up period. The occurrence of each complicaiton/adverse event will be compared to the occurrence of the same complication by similar products or other state of the art treatments	From baseline to the end of last follow-up [average of minimum 3 months]
Anatomical success (POP-Q)	POP-Q system according to ICS with POP-Q stages 0, I, II, III, IV The postoperative POP-Q stages (overall, apical compartment, anterior compartment, posterior compartment) will be compared to the preoperative POP-Q stages.	From baseline to the end of last follow-up [average of minimum 3 months]

Collaborators and Investigators

• Sponsor: A.M.I. Agency for Medical Innovations GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: surgical mesh; Sacrocolpopexy; Sacrocervicopexy; laparoscopic mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: PMCF-4.2-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No