Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol

Servicio de Salud Metropolitano Sur Oriente

Status: Unknown

Conditions: Quality of Life; Pelvic Organ Prolapse

Treatments: Device: Vaginal Pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT02113969

SA12I2153

Details and patient eligibility

About

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

Enrollment: 294 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic Pelvic Organ Prolapse
• Commitment to attend controls
• Current negative cervical cytology
• Informed consent signed

Exclusion criteria

• Urinary incontinence as the only Pessary Indication
• Vaginal bleeding of undetermined cause
• Unable to return to controls

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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294 participants in 1 patient group

Vaginal Pessary

Experimental group

Description:

Pessary users for at least 12 months

Treatment:

Device: Vaginal Pessary