I-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

• Conditions: Pelvic Organ Prolapse; Genital Prolapse

• Registration Number: NCT06805006
• Lead Sponsor: A.M.I. Agency for Medical Innovations GmbH

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective outcome	3 months	German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Isar Kliniken GmbH; 🇩🇪 Munich, Bavaria, Germany