Pessary Satisfaction Criteria for Urogenital Prolapse

Study Overview
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Brief Summary
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Genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used. The use of pessary in the treatment of prolapse remains discussed despite a satisfaction rate of 50 to 80% in the literature and a minimal complications rate. The main objective of this study is to assess the satisfaction of patients carrying a pessary in the first year after the laying.

Detailed Description
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This is a prospective observational cohort conducted at the Universitary hospital of Caen over a total period of 5 years. Patients with a symptomatic genital prolapse will all be offered the installation of a pessary. If they agree to participate in the study, they will be asked to respond to validated questionnaires: symptom questionnaires (PFDI-20, ICIQ-SF, USP), a sexuality questionnaire (PISQ-12), a quality of life questionnaire (PFIQ-7, BIS) and Satisfaction (PGI-I), several times: Before the installation of the pessary, at one month, at 6 months, then annually over 5 years

Official Title
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Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse

Conditions
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Pessary, Genital Prolapse, Satisfaction

Intervention / Treatment
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* Device: pessary use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The research protocol will be proposed to all patients with a symptomatic genital prolapse, over 18 years of age, who speak French and who agree to participate in this study Prolapse defined according to the International Classification POP-Q-. Exclusion Criteria: Minors under 18 years of age Pregnant or lactating women Women Not speaking French (the good understanding of French is necessary to answer questionnaires and for informed information) Women unable to understand due to cognitive impairment or degenerative disease (dementia/ Alzheimer's disease)

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pessary use|evaluation of satisfaction of pessary use in case of symptomatic genital prolapse|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary | The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) every year for five years after the installation of a pessary | The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments | 1 to 5 years | 
| EFFICACY of pessary on genital symptoms assessed by the Pelvic Floor Distress Inventory (PFDI-20) questionnaire before and after the installation of the pessary. | This score was developped to evaluate the genital, anorectal and urinary symptoms related to genital prolapse | at 1 year, then every year for 5 years | 
| EFFICACY of pessary on urinary symptoms assessed by the International Consultation of Incontinence Questionnaire-Short Form (ICIQ-UI SF) and the Urinary Symptom Profile score (USP) before and after the installation of the pessary. | These scores are self-questionnaires specifically validated to evaluate urinary incontinence and urinary tract dysfunctions | at 1 year, then every year for 5 years | 
| Sexual impact of pessary assessed by the Pelvic organ prolapse urinary Incontinence Sexual Questionnaire (PISQ-12) | Evaluation of the PISQ-12 score after the installation of a pessary. This score was developped specifically to evaluate sexual troubles in case of genital prolapse | at 1 year, then every year for 5 years | 
| QUALITY OF LIFE assessed by the Pelvic Floor Impact Questionnaire (PFIQ-7) before and after the installation of the pessary | The PFIQ-7 was developped to evaluate the impact of the symptoms on the quality of life | at 1 year, then every year for 5 years | 
| INVESTIGATE the impact of age on the removal or expulsion of pessary | Impact of age (years) on treatment failure (removal or expulsion of pessary) | 1 year to 5 years | 
| INVESTIGATE the impact of menopausal status on the removal or expulsion of pessary | Impact of menopausal status (yes/no) on treatment failure (removal or expulsion of pessary) | 1 year to 5 years | 
| INVESTIGATE the impact of weight on the removal or expulsion of pessary | Impact of weight (Kg) on treatment failure (removal or expulsion of pessary) | 1 year to 5 years | 
| INVESTIGATE the impact of hysterectomy history on the removal or expulsion of pessary | Impact of hysterectomy history (yes/no) on the removal or expulsion of pessary | 1 year to 5 years | 
| INVESTIGATE the impact of prolapse surgery history on the removal or expulsion of pessary | Impact of prolapse surgery history (yes/no) on the removal or expulsion of pessary | 1 year to 5 years | 
| INVESTIGATE the impact of the prolapse stage of on the removal or expulsion of pessary | Impact of the prolapse stage (assessed by the validated POP-Q classification) of on the removal or expulsion of pessary. The stage of prolapse is ranged from 1 to 4 in the POP-Q classification | 1 year to 5 years | 
| Complications of pessary use reported by their rate | Rate of complications related to the use of a pessary (frequencies) | 1 to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, efficiency