Retrospective monocentric cohort study to evaluate the efficacy and safety of Splentis for transvaginal sacrospinal fixation of the primary apical prolapse

• Conditions: N81.4; Uterovaginal prolapse, unspecified

• Registration Number: DRKS00021072
• Lead Sponsor: Promedon GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-09-30
• Study Start: 2021-03-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 110

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

1. Patient is unwilling or capable of giving informed consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure from apical and anterior pelvic organ prolapse. Cure is defined according POP-Q = 1 at the time of last follow-Up

Secondary Outcome Measures

Name	Time	Method
1) Number of Patients with improvement of quality of life according the german questionnaire (deutscher Beckenbodenprolaps Fragebogen) <br>2) Number of adverse events<br>3) Number of patients with pain as well as severity categoriation according visual analogue scale of pain. <br>4) Number of patients who are satisfied with the intervention<br>5) Number of surgical revisions as well as estimated revision and explantation free survival according Kaplan Meier <br>6) Estiamted recurrent free survival according kaplan-meier