The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
Study Type
OBSERVATIONAL
Enrollment
80
Patient received PelviGYNious implant.
Patient received EndoGYNious implant.
Universitätsklinikum Erlangen, Frauenklinik
Erlangen, Germany
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.
Time frame: From baseline to the end of last follow-up [3 months, 12 months]
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
Time frame: 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.
Time frame: From baseline to the end of last follow-up [average of minimum 3 months]
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