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

May 20, 2024 updated by: Stefano Salvatore, IRCCS San Raffaele
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with symptomatic and documented POP (stages III and IV) through POPQ examination who opted for reconstructive surgery and managed with pessary until surgery will be included in the cohort.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate a change in POPQ points 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POP-ES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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