Retrospective Data Analysis PelviGYNious/EndoGYNious

Active, not recruiting

• Conditions: Prolapse; Sacrocolpopexy; Pelvic Organ Prolapse (POP)

• Registration Number: NCT06927752
• Lead Sponsor: A.M.I. Agency for Medical Innovations GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2025-03-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient subjective outcome	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 Outcome Measures

Name	Time	Method
Postoperative complications	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
Anatomical success (POP-Q)	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.

Trial Locations

Locations (1)

Universitätsklinikum Erlangen, Frauenklinik; 🇩🇪 Erlangen, Germany