Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair (CASPO)
Pelvic Organ Prolapse
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring surgical mesh, surgery, Therapy, pelvic floor disorders, cystocele
Eligibility Criteria
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
- Fertile women
- Patients with active or latent infection of the vagina, cervix or uterus
- Patients with previous or current vaginal, cervical or uterine cancer
- Previous, current or planned pelvic radiation therapy
- 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
Sites / Locations
- Helios Hospital Erfurt, Department of gynaecologyRecruiting
- St. Hedwig HospitalRecruiting
- Evangelic Diakonie HospitalRecruiting
- St. Elisabeth-Hospital LeipzigRecruiting
- Hospital TettnangRecruiting
- University Hospital TübingenRecruiting
Arms of the Study
Arm 1
Experimental
Calistar S
Single arm cohort trial