The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
Not yet recruiting
- Conditions
- Vaginal ProlapsePelvic Organ Prolapse
- Registration Number
- NCT06234449
- Lead Sponsor
- IRCCS San Raffaele
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IRCCS San Raffaele Hospital
🇮🇹Milan, Italy