The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
The i-Stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. It is used together with the i-Stitch loading units. The use of i-Stitch for the fixation of surgical urogynaecological mesh implants (e.g. BSC Mesh, InGYNious) has already been proven in several studies. The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.
Study Type
OBSERVATIONAL
Enrollment
100
Bilateral sacrospinous ligament fixation with i-Stitch device
Isar Kliniken GmbH
Munich, Bavaria, Germany
Subjective outcome
German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")
Time frame: 12 months
Subjective outcome
German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")
Time frame: 3 months
Quality of life (ICIQ-UI SF)
urinary incontinence and its impact on quality of life using the short form of the International Consultation on Incontinence Questionnaire
Time frame: 12 months
Postoperative complications
Complications in women undergoing bilateral SSLF using the i-Stitch
Time frame: 12 months
Anatomical outcome (POP-Q)
Objective anatomical failure/recurrent prolapse in any anatomical compartment
Time frame: 12 months
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