An observational study in Pelvic Organ Prolapse and Vaginal Prolapse, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to female participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by IRCCS San Raffaele · Observational
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
111 studies on the registry are indexed under Uterine Prolapse; 18 are open to participants now.
This study's planned enrollment of 200 is above the median of 99 across 34 observational studies indexed under Uterine Prolapse.
Browse Uterine Prolapse studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
Compared within Uterine Prolapse, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pelvic Organ Prolapse. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
use of vaginal pessary for patients waiting for gynecological surgery for stage III and IV pelvic organ prolapse
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.
Time frame: At the time of surgery procedure, after at least 6 months after pessary placement
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Mar 2026, 20 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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