The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery

N/ANot Yet RecruitingNCT06234449

IRCCS San Raffaele200 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Pelvic Organ Prolapse Vaginal Prolapse

Interventions

Vaginal pessary before surgery for pelvic organ prolapsePROCEDURE

use of vaginal pessary for patients waiting for gynecological surgery for stage III and IV pelvic organ prolapse

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS San Raffaele Hospital

Milan, Italy

Outcomes

Primary Outcomes

evaluate a change in POPQ points on examination at the time of surgery from baseline evaluation.

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.

Time frame: At the time of surgery procedure, after at least 6 months after pessary placement

Data from ClinicalTrials.gov

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