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

NCT06234449 | Not Yet Recruiting

• 1 other identifier: POP-ES
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Organ Prolapse; Vaginal Prolapse

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Vaginal pessary before surgery for pelvic organ prolapse PROCEDURE

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

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pelvic organ prolapse with POP-Q stage \>/= 3 in anterior and/or central compartments
• Women between 45 and 80 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: January 31, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

IT (1)