Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorA.M.I. Agency for Medical Innovations GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Laparoscopic lateral suspension with surgical mesh (LatGYNious)
DeviceLaparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
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 surgery3
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.Sponsors and contacts
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Source ClinicalTrials.gov