Pelvic Organ Prolapse, Vaginal Prolapse
Conditions
Brief summary
Patients aged 45 to 80 years with a clinical diagnosis of stage III and IV genital prolapse involving the anterior and/or middle compartments and candidates for surgery will be considered. These will be evaluated to observe whether there is improvement in clinical prolapse with the use of the vaginal pessary during the waiting period for surgery
Interventions
PROCEDUREVaginal pessary before surgery for pelvic organ prolapse
use of vaginal pessary for patients waiting for gynecological surgery for stage III and IV pelvic organ prolapse
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Pelvic organ prolapse with POP-Q stage \>/= 3 in anterior and/or central compartments * Women between 45 and 80 years old
Exclusion criteria
* Women who refuse to participate in the study * Patients without baseline POPQ examination documented or with a pessary previously positioned * Previous pelvic surgeries * Women with any contraindication for surgery or preference for conservative treatment only (pelvic muscle exercise, vaginal pessary) * Women who are not successfully fitted with pessaries * Current genital ulcers/infections * Active or chronic pelvic infection * Women who are mentally incapable of completing the questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate a change in POPQ points on examination at the time of surgery from baseline evaluation. | At the time of surgery procedure, after at least 6 months after pessary placement | Primary endopoint is the evaluation of the percentage of women who experience a change in any POPQ point on examination at the time of surgery from baseline evaluation. |
Countries
Italy
Outcome results
None listed