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Active, Not Recruiting

NCT Number: NCT06927752

Retrospective Data Analysis PelviGYNious/EndoGYNious

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Pelvic Organ Prolapse (POP) Sacrocolpopexy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Universitätsklinikum Erlangen, Frauenklinik

Erlangen, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PelviGYNious

Device

Patient received PelviGYNious implant.

EndoGYNious

Device

Patient received EndoGYNious implant.

Primary outcomes

  1. Patient subjective outcome

    Time frame: From baseline to the end of last follow-up [3 months, 12 months]

    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.

Secondary outcomes

  1. Postoperative complications

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

    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

  2. Anatomical success (POP-Q)

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

    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.

Sponsors and collaborators

Lead sponsor

A.M.I. Agency for Medical Innovations GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

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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