Overview
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement
Description
Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is intended for transvaginal reestablishment and reinforcement of the physiologic anatomy of the female pelvic floor in non-fertile women with anterior pelvic organ prolapse with or without apical vaginal wall involvement in both, recurrent pelvic organ prolapse and primary pelvic organ prolapse when other surgical procedures are expected to fail (i.e. complex primary prolapse).
The treatment kit consists of the lightweight mesh, two single-use introducers and 3 tissue anchoring system (TAS) anchors for fixation to the sacrospinous ligament. The product is approved in accordance with the CE Directive 93/42/EEC.
The utilization of synthetic implants in POP repair became increasingly popular in the last decade. The cumulative success rate of synthetic implants in anterior compartment repair is as high as up to 93%.However, meshes have been recently scrutinized due to high adverse event reporting after unreflected utilization of meshes which raised concerns of patients safety; furthermore taking into account the complexity of adverse event mesh management. This led to a vanishing of various meshes in transvaginal POP repair. Nevertheless, the further development of light weight meshes, the experience of the surgeon and the assessment and patients selection are well known factors reducing the rate of adverse events significantly.
Therefore, in the current trial the efficacy and safety of calistar S in a highly selected patient population will be evaluated.
Eligibility
Inclusion criteria Non-fertile women > 18 years1 2. Symtomatic anterior prolapse with or
without apical vaginal wall involvement according POP-Q score ≥ 2. (Corresponding to Aa, Ba
≥ -1 and where applicable C ≥ -1/2 TVL ).
3. Subjects with recurrent prolapse or complex primary prolapse are eligible for the study.
4. Scheduled mesh-augmented anterior POP repair with Calistar S 5. Signed inform consent
Exclusion criteria
1. Fertile women
2. Patients with active or latent infection of the vagina, cervix or uterus
3. Patients with previous or current vaginal, cervical or uterine cancer
4. Previous, current or planned pelvic radiation therapy
5. Known allergy to polypropylene
7. Subject is unable or unwilling to complete questionnaires (either self-administered,
assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent