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NCT Number: NCT07066761

Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)

The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.

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Key information

Conditions

Pelvic Organ Prolapse (POP) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Prolapse Laparoscopic Surgery Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases Uterine Prolapse Uterus Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BZK St. Johann in Tirol, Sankt Johann in Tirol, Tyrol, Austria

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About this study

LatGYNious is a preformed mesh implant which combines two types of polypropylene meshes with different properties. The mesh body is made of ultra-light monofilament polypropylene with a wide hexagonal pore structure with a high level of elasticity. A reinforced mesh material with a smaller pore structure is used for the mesh arms, which achieves a strong lateral fixation. The overlap area of the two mesh types is designed to combine the properties of both structures. In case of a uterus preserving approach, the posterior part of the mesh body is removed.

The aim of the present study is to generate clinical data to show the safety and performance of LatGYNious for the treatment of female pelvic organ prolapse.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic prolapse in one of the 3 compartments from grade 2 with or without uterus
  • Subject is candidate for a surgical treatment of pelvic organ prolapse
  • Subject is willing and able to cooperate with follow-up examinations
  • Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.

Exclusion criteria

  • Previous surgical treatment with a mesh implant for pelvic organ prolapse (mesh implant in anterior or posterior compartment)
  • Active immunotherapy which may negatively affect the treatment with a surgical mesh
  • Active cancer of the vagina / cervix / rectum
  • . known or suspected hypersensitivity to Polypropylene
  • Pregnancy
  • participation in another study at the same time
  • Unable to understand study requirements or is unable to comply with follow-up schedule
  • Contraindicated according to the instruction for use of the device

Treatment and study plan

Laparoscopic lateral suspension with surgical mesh (LatGYNious)

Device

Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)

Other names: surgical POP treatment, Pelvic organ prolapse

Primary outcomes

  1. Objective success

    Time frame: During follow-up until 6 and 12 months after surgery

    The primary objective is to confirm the effectiveness and objective success rate (anatomical correction defined by POP-Q) of a laparoscopic lateral mesh implant.

    Objective success is determined by anatomical measurement (POP-Q) pre- and post-operatively.

    Objective cure is defined as:

    • POP-Q values Ba, C and Bp < -1 (according to Barber et al.).
    • Absence of pelvic floor prolapse/bulge symptoms based on questionnaire (P-QoL).
    • No additional POP treatment necessary

Secondary outcomes

  1. Quality of Life (QoL)

    Time frame: During follow-up until 6 and 12 months after surgery

    Quality of Life is determined by a validated questionnaire (P-QoL).

    The P-QoL Total score ranging from 0 points (complete continence) to 24 points (complete incontinence). An intra-individual comparison of preOP data vs. postOP data will be performed (for each follow-up).

  2. Subjective success

    Time frame: During follow-up until 6 and 12 months after surgery

    Subjective rating of pelvic floor function is determined by a validated questionnaire (Deutscher Beckenboden-Fragebogen / German Pelvic Floor Questionnaire (GPFQ)).

    The GPFQ consist of 42 items, where each item has its scores. The scores were summed up for each category (bladder max. 45, bowel max. 34, prolapse max. 15, sexual max. 21).

    The final score were calculated as follows:

    (achieved value of category/ max. value of category)*10 Therefore, the max. value is 10 for each category and the final score is maximum 40.

    An intra-individual comparison of preOP data vs. postOP data will be performed (for each follow-up).

  3. Complications

    Time frame: From operation during follow-up until 6 and 12 months after surgery.

    All adverse events will be reported.

    Serious device- and procedure-related adverse events will be summarized separately.

Study contacts

Contact information is provided by the study sponsor or research team.

Florian Blab

CONTACT

[email protected]

+43 5522 90505 4062

Sponsors and collaborators

Lead sponsor

A.M.I. Agency for Medical Innovations GmbH

Industry

Registry information

Official study title

Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 15, 2025
Registry last updated
Jul 28, 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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