Genital Prolapse, Pelvic Organ Prolapse
Conditions
Keywords
bilateral sacrospinous ligament fixation, suture attachment medical device
Brief summary
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.
Detailed description
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.
Interventions
DEVICESSLF
Bilateral sacrospinous ligament fixation with i-Stitch device
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 * SSLF with usage of i-Stitch device (\& i-Stitch Loading Units) * Concomitant procedures are allowed * Women minimum 18 years old * Written informed consent for surgery
Exclusion criteria
* infection (active or latent) * allergies to the materials used * benign or malignant changes * anticoagulation disorders * autoimmune connective tissue disorders * any uterus pathologies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective outcome | 12 months | German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen") |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (ICIQ-UI SF) | 12 months | urinary incontinence and its impact on quality of life using the short form of the International Consultation on Incontinence Questionnaire |
| Postoperative complications | 12 months | Complications in women undergoing bilateral SSLF using the i-Stitch |
| Anatomical outcome (POP-Q) | 12 months | Objective anatomical failure/recurrent prolapse in any anatomical compartment |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORUrsula Peschers, Prof. Dr.
ISAR Klinikum Munich
Outcome results
None listed