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.
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
Study Type
OBSERVATIONAL
Enrollment
150
evaluation of satisfaction of pessary use in case of symptomatic genital prolapse
Pizzoferato
Caen, France
RECRUITINGPatient 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
Time frame: 1 year
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 1 year, then every year for 5 years
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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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year to 5 years
Complications of pessary use reported by their rate
Rate of complications related to the use of a pessary (frequencies)
Time frame: 1 to 5 years