i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF) (i-StitchSSLF)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pelvic Organ Prolapse; Genital Prolapse
• Intervention / Treatment: Device: SSLF

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80331
      • Isar Kliniken GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic pelvic organ prolapse indicated for a surgical intervention.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective outcome	German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")	12 months
Subjective outcome	German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
Postoperative complications	Complications in women undergoing bilateral SSLF using the i-Stitch	12 months
Anatomical outcome (POP-Q)	Objective anatomical failure/recurrent prolapse in any anatomical compartment	12 months

Collaborators and Investigators

• Sponsor: A.M.I. Agency for Medical Innovations GmbH
• Investigators: Principal Investigator: Ursula Peschers, Prof. Dr., ISAR Klinikum Munich

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: bilateral sacrospinous ligament fixation; suture attachment medical device
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse
• Other Study ID Numbers: PMCF-03-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No