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

NCT ID: NCT06234449

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Pelvic Organ Prolapse Vaginal Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Stefano Salvatore

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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POP-ES

Identifier Type: -

Identifier Source: org_study_id

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