i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSLF.
- Who it may be relevant to
- Registry conditions: Pelvic Organ Prolapse, Genital Prolapse. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device SSLF
Bilateral sacrospinous ligament fixation with i-Stitch device
Primary outcome measures
- Subjective outcome [Time frame: 12 months]
- Subjective outcome [Time frame: 3 months]
Secondary outcome measures (3)
- Quality of life (ICIQ-UI SF) [Time frame: 12 months]
- Postoperative complications [Time frame: 12 months]
- Anatomical outcome (POP-Q) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Isar Kliniken GmbH — Munich
Identifiers
NCT: NCT06805006 · PMCF-03-011