Retrospective Data Analysis PelviGYNious/EndoGYNious

NCT06927752 | Active Not Recruiting DMC

• 1 other identifier: PMCF-4.2-004
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prolapse; Sacrocolpopexy; Pelvic Organ Prolapse (POP)

Keywords

Sacrocolpopexy; Sacrocervicopexy; surgical mesh; laparoscopic mesh

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative complications

  From baseline to the end of last follow-up [average of minimum 3 months]

• Anatomical success (POP-Q)

  From baseline to the end of last follow-up [average of minimum 3 months]

Study Arms (2)

EndoGYNious

Patient received EndoGYNious mesh implant.

Device: EndoGYNious

PelviGYNious

Patient received PelviGYNious mesh implant.

Device: PelviGYNious

Interventions

PelviGYNious DEVICE

Patient received PelviGYNious implant.

PelviGYNious

EndoGYNious DEVICE

Patient received EndoGYNious implant.

EndoGYNious

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Universitätsklinikum Erlangen, Frauenklinik

Erlangen, Germany

Location

MeSH Terms

Conditions

Prolapse; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 15, 2025
• Study Start: April 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)