Pelvic Organ Prolapse (POP), Prolapse, Sacrocolpopexy
Conditions
Keywords
Sacrocolpopexy, Sacrocervicopexy, surgical mesh, laparoscopic mesh
Brief summary
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
Interventions
DEVICEPelviGYNious
Patient received PelviGYNious implant.
DEVICEEndoGYNious
Patient received EndoGYNious implant.
Sponsors
A.M.I. Agency for Medical Innovations GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed