prolapse uterine descent
Conditions
Interventions
Random allocation to vaginal sacrospinous hysteropexy or laparoscopic
sacrohysteropexy.
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Uterine descent POP-Q stage >= 2 requiring surgery. Patients with co-existing anterior/posterior defects or concomitant incontinence surgery (TVT-O) can be included.
Exclusion criteria
Exclusion criteria: Previous pelvic floor or prolapse surgery Wish to preserve fertility Known malignancy or abnormal cervical smears Unwilling to return for follow-up or language barriers Presence of immunological/haematological disorders interfering with recovery after surgery Contraindications for laparoscopic surgery (ileus, risk of severe adhesions) Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anatomical outcome and recurrence rate assessed by the POP-Q test at 1 and 5 years follow-up. Recurrence rate is defined as uterine prolapse >= 2 with symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery and sexual functioning, costs-effectiveness. | — |
Countries
Netherlands
Outcome results
None listed