Pessary Satisfaction Criteria for Urogenital Prolapse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Caen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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-.
Disqualifiers
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)
Trial population
The research protocol will be proposed to all patients with a symptomatic genital prolapse
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
pessary use
Deviceevaluation of satisfaction of pessary use in case of symptomatic genital prolapse
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
1 yearSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov