The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
Launched by IRCCS SAN RAFFAELE · Jan 29, 2024
Trial Information
Current as of July 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of using a vaginal pessary on women with pelvic organ prolapse, particularly during the waiting period for surgery. A pessary is a device that is placed in the vagina to help support pelvic organs that may be sagging or prolapsing. The trial focuses on women aged 45 to 80 who have been diagnosed with more advanced stages of pelvic organ prolapse. Researchers want to see if using a pessary can improve their condition while they wait for surgery.
To be eligible for the trial, participants must be women between 45 and 80 years old who have a specific type of pelvic organ prolapse that requires surgery. However, women with certain health issues or those who have had previous pelvic surgeries will not be able to participate. Those who join the study can expect to be fitted with a pessary and monitored to see how it affects their symptoms. This trial is important because it may provide insights into managing pelvic organ prolapse while patients wait for surgical treatment, especially during challenging times like the COVID-19 pandemic.
Gender
FEMALE
Eligibility criteria
- 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.
About Irccs San Raffaele
IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported