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

Study Overview
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Brief Summary
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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

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

Conditions
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Pelvic Organ Prolapse, Quality of Life

Intervention / Treatment
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* Device: Vaginal Pessary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Pessary<br>Pessary users for at least 12 months | Device: Vaginal Pessary<br>* Pessary fitting session at recruitment, follow up at 1 week, then monthly to complete 1 year follow up. QoL, symptoms and sexual function Surveys will be conducted at recruitment, 6 and 12 month. The absence of bacterial vaginosis (through study of vaginal discharge and pH) will be checked prior to positioning pessary and then each control. At the end of follow up period the success related variables will be determine with a statistical model. This information will be analyzed by an expert panel aiming to identify relevant clinical variables not included. This panel will generate a Standardized Management Protocol for symptomatic pelvic organ prolapse using vaginal pessaries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life changes in pessary users for symptomatic Pelvic Organs Prolapse | At baseline, 6 and 12 month the Chilean Version of the P-QoL survey will be applied to describe the QoL changes | 6 months and 12 months | 
| Pelvic Floor Disorders symptoms changes in pessary users for symptomatic Pelvic Organs Prolapse | At baseline, 6 and 12 month the Chilean Version of the Pelvic Distress Inventory - 20 (PDFI-20) survey will be applied to describe the symptoms changes | 6 months and 12 months | 
| Sexual response changes in pessary sexually active women users for symptomatic Pelvic Organs Prolapse | At baseline, 6 and 12 month the Chilean Version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) survey will be applied to describe the Sexually response changes | 6 months and 12 months | 
| Subjective impression of improvement after pessary use for symptomatic Pelvic Organs Prolapse | At baseline, 6 and 12 month the Patient Global Impression of Improvement (PGI-I) survey will be applied to describe the subjective improvement | 6 months and 12 months | 
| Successful usage of pessary | If an enrolled patients is still using the pessary as the treatment for the pelvic organ prolapse will be considered as successful. Risk factors for unsuccessful pessary used will be measure using baseline characteristics. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Organ Prolapse, Quality of Life, Symptoms, Pessary, Treatment