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

A.M.I. Agency for Medical Innovations GmbH85 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pelvic Organ Prolapse (POP)Genital Prolapse Uterus Prolapse Laparoscopic Surgery

Interventions

Laparoscopic lateral suspension with surgical mesh (LatGYNious)DEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

BZK St. Johann in Tirol

Sankt Johann in Tirol, Tyrol, Austria

RECRUITING

LKH Feldkirch, Gynäkologie und Geburtshilfe

Feldkirch, Austria

RECRUITING

Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe

Brandenburg, Germany

Outcomes

Primary Outcomes

Objective success

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

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

Secondary Outcomes

Quality of Life (QoL)

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).

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

Subjective success

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).

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

Complications

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

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

Central Contacts

Florian Blab

CONTACT

+43 5522 90505 4062 florian.blab@ami.at

Data from ClinicalTrials.gov

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