N81.4
Conditions
Interventions
Group 1: Women, who underwent bilateral sacrospinous hysteropexy with splentis for apical prolapse will be retrospectively enrolled and anatomical results (at last clinical follow up) as well quality
Sponsors
Promedon GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. women = 18 Jahre 2. History of transvaginal bilateral sacrospinal fixation by splentis of an apical pelvic organ prolapse 3. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patient is unwilling or capable of giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure from apical and anterior pelvic organ prolapse. Cure is defined according POP-Q = 1 at the time of last follow-Up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number of Patients with improvement of quality of life according the german questionnaire (deutscher Beckenbodenprolaps Fragebogen) 2) Number of adverse events 3) Number of patients with pain as well as severity categoriation according visual analogue scale of pain. 4) Number of patients who are satisfied with the intervention 5) Number of surgical revisions as well as estimated revision and explantation free survival according Kaplan Meier 6) Estiamted recurrent free survival according kaplan-meier | — |
Countries
Germany
Contacts
Public ContactAndreas Spicker
Promedon GmbH
Outcome results
None listed