Pelvic Organ Prolapse
Conditions
Brief summary
This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.
Interventions
PROCEDUREBilateral sacrospinous fixation
Bilateral sacrospinous vaginal suspension
Sponsors
University Hospital Tuebingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 and above * pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus * signed informed consent
Exclusion criteria
* gynecologic surgery in the three past months before planned surgery * history of prolapse surgery * participation in another study * need to simultaneously perform other surgical procedures (i.e. rectopexy) * ongoing chemotherapy of treatment with immunosuppressant drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pelvic floor symptoms | Twelve months | Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical outcome / Prolapse stage after surgery | Twelve months | Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996) |
| Changes in quality of life | Twelve months | Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) |
| Changes in sexual activity | Twelve months | Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004) |
Countries
Germany
Contacts
Primary ContactTilemachos Kavvadias, MD
Outcome results
None listed