Female Pelvic Organ Prolapse
Conditions
Interventions
Calistar S for transvaginal pelvic organ prolapse repair
Sponsors
AMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-pregnant women > 18 years defined by postmenopausal status and / or iatrogenic causes which exclude women permanently from becoming pregnant (e.g. history of hysterectomy or sterilised women). 2. Anterior prolapse with or without apical vaginal wall involvement according POP-Q score = 2 3. Subjects with recurrent prolapse as well as primary complex prolapse when other surgical procedures are expected to fail (i.e. high risk for recurrence) are eligible for the study. 4. Scheduled mesh-augmented anterior POP repair with Calistar S
Exclusion criteria
Exclusion criteria: 1. Pregnant 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 6. Ulcus of the vaginal wall 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with surgical treatment success of anterior and apical pelvic organ prolapse after 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, sexual function, complication rates, revision and explantation free survival, surgical treatment for urinary stress incontinence, cure in short, mid-term, and long-term follow-Up. | — |
Contacts
Public ContactGert-Jan van Baaren
AMC
Outcome results
None listed