pelvic organ prolapse vaginal descent
Conditions
Interventions
INTERVENTION(S)
Sacrospinous hysteropexy (SSH):
After opening the posterior vaginal wall, the pararectal space is explored at
the right side and the sacrospinous ligament is
identified. The posterior
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women with symptomatic pelvic organ prolapse including uterine descent. The prolapse may be at any stage but POP-Q point D may not exceed minus 1cm. Community dwelling Capable of filling out questionnaires Patients from the hospitals in Nijmegen, Zwolle, Almelo, Hengelo and Enschede) are asked to participate in a supine and upright MRI scan at the University of Twente.
Exclusion criteria
Exclusion criteria: - 47cm (jeans size >44) - Not allowed to do a maximum Valsalva manoeuvre because of cardiac or pulmonary disease - Not eligible for MRI, in response to the MRI safety checklist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OUTCOME PARAMETERS/TIME: Primary outcome: *Composite success*, defined as a combination of: 1) absence of POP beyond the hymen in any compartment, 2) absence of bulge symptoms and 3) absence of reoperation for POP. Absence of bulge symptoms is defined as a negative response to the question, *Do you see or feel a bulge in the vaginal area* (UDI domain genital prolapse score: 0). This outcome is generally referred to as Barber criteria. The composite outcome was chosen as the most patient relevant outcome because it accounts for anatomic changes in any compartment, bulge symptoms, and the need for retreatment. Vaginal bulge symptoms postoperatively had a significant relationship with patient*s assessment of overall improvement, while anatomic success alone did not. Success is defined as achieving optimal anatomy and function in 1 operation and thus need for a reoperation is defined as failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: - Hospital parameters (surgery time, hospitalisation time) - Surgery related morbidity/complications (including menstrual problems, hematometra, any problems with uterine access such as diagnostic cervical or endometrial sampling or IUD insertion) - Further treatments for POP or UI - POP-Q: anatomy in all compartments - Generic quality of life: Euroqol 5D-5L (EQ-5D-5L) (6 questions) - Disease specific quality of life: Regarding symptoms: Pelvic Floor Distress Inventory (PDFI-20) (20 questions) Regarding the impact of symptoms: Patient Global Impression of Improvement (PGI-I) (1 question) Pelvic Floor Impact Questionnaire (PFIQ-7) (7 questions) - Sexual function: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) (20 questions) - Pain perception: VAS score pelvic pain: rest, activity (2 questions) - Costs | — |
Countries
Netherlands
Outcome results
None listed