Genital Prolapse, Laparoscopic Surgery, Pelvic Organ Prolapse (POP), Uterus Prolapse
Conditions
Keywords
Laparoscopic lateral suspension (LLS)
Brief summary
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.
Detailed description
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.
Interventions
DEVICELaparoscopic lateral suspension with surgical mesh (LatGYNious)
Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)
Sponsors
A.M.I. Agency for Medical Innovations GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective success | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | 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). |
| Subjective success | 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). |
| Complications | 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. |
Countries
Austria, Germany
Contacts
CONTACTFlorian Blab
PRINCIPAL_INVESTIGATORTina Cadenbach-Blome, Dr. med.
Medizincampus Bodensee - Klinik Tettnang
Outcome results
None listed