Quality of Life Clinical Trial
Official title:
Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol
Genital prolapse is a common condition (up 20%), affecting the quality of life. Treatment
can be surgical or conservative using vaginal pessaries. These devices are introduced into
the vagina aiming to reduces the prolapse.
Pessaries have shown effectiveness in improving symptoms and quality of life. There are no
randomized studies comparing them with surgery. This study design would be difficult to
perform, because the inclusion criteria for both treatments are different. There are no
currently standard protocols for the use of pessaries. This makes harder to widespread the
usage of this conservative treatment.
The aim of the investigators is to identify variables that influence the success of
conservative management of genital prolapse at 1 year of follow up. Using these variables
and an expert panel opinion the investigators will develop a standardized protocol for
pessary management.
Chile has a primary gynecological care system based midwives. Therefore having algorithms
for pessaries usage becomes relevant. This algorithm can be implemented with basic training.
This would increase the respond capacity, by the health care system to this disease,
considering the scarce access to surgery.
The investigators hypothesis is: It is possible to generate a standardized protocol of
conservative management of symptomatic genital prolapse in patient's beneficiary of public
health system in Santiago, Chile, using pessaries through a prospective cohort study based
in the success of these devices with 1 year of follow up, measured with questionnaires of
symptoms, quality of life and sexuality
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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