Pelvic Organ ProlapseNCT06234449
The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
An observational study of Pelvic Organ Prolapse and Vaginal Prolapse, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Vaginal Prolapse
- What is being tested?
- Vaginal pessary before surgery for pelvic organ prolapse
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2024to Mar 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Pelvic organ prolapse with POP-Q stage >/= 3 in anterior and/or central compartments
- Women between 45 and 80 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Vaginal pessary before surgery for pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal pessary before surgery for pelvic organ prolapseProcedure or surgery
use of vaginal pessary for patients waiting for gynecological surgery for stage III and IV pelvic organ prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of surgery procedure, after at least 6 months after pessary placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study startJul 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Salvatore, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234449
- Sponsor's protocol ID
- POP-ES
- Status last verified
- May 2024
- First submitted
- 25 Jan 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
- ClinicalTrials.gov ID
- NCT06234449
- Acronym / sponsor ID
- POP-ES
- Conditions
- Pelvic Organ Prolapse, Vaginal Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Pelvic organ prolapse with POP-Q stage >/= 3 in anterior and/or central compartments
- Women between 45 and 80 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal pessary before surgery for pelvic organ prolapseuse of vaginal pessary for patients waiting for gynecological surgery for stage III and IV pelvic organ prolapse | Procedure or surgery | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Vaginal Prolapse, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.