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NCT06234449 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06234449
Other study ID # POP-ES
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date March 2026

Study information
Verified date January 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Vaginal 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

Locations
Country Name City State
Italy IRCCS San Raffaele Hospital Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. At the time of surgery procedure, after at least 6 months after pessary placement
See also
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