Transvaginal mesh for anterior pelvic organ prolapse repair
Transvaginal mesh for anterior pelvic organ prolapse repair: synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population
Study summary
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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of Patients with Cure of pelvic organ prolapse — 24 months Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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