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

S

San Donato Group (GSD)

Status

Begins enrollment this month

Conditions

Vaginal Prolapse
Pelvic Organ Prolapse

Treatments

Procedure: Vaginal pessary before surgery for pelvic organ prolapse

Study type

Observational

Funder types

Other

Identifiers

NCT06234449
POP-ES

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

Female

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems