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Enrolling by Invitation

NCT Number: NCT06805006

i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

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.

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Key information

Conditions

Pelvic Organ Prolapse Genital Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Isar Kliniken GmbH

Munich, Bavaria, 80331, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SSLF

Device

Bilateral sacrospinous ligament fixation with i-Stitch device

Primary outcomes

  1. Subjective outcome

    Time frame: 12 months

    German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")

  2. Subjective outcome

    Time frame: 3 months

    German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")

Secondary outcomes

  1. Quality of life (ICIQ-UI SF)

    Time frame: 12 months

    urinary incontinence and its impact on quality of life using the short form of the International Consultation on Incontinence Questionnaire

  2. Postoperative complications

    Time frame: 12 months

    Complications in women undergoing bilateral SSLF using the i-Stitch

  3. Anatomical outcome (POP-Q)

    Time frame: 12 months

    Objective anatomical failure/recurrent prolapse in any anatomical compartment

Sponsors and collaborators

Lead sponsor

A.M.I. Agency for Medical Innovations GmbH

Industry

Registry information

Acronym: i-StitchSSLF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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