Pessary Satisfaction Criteria for Urogenital Prolapse (PeSaCUP)

Caen University Hospital

Status: Enrolling

Conditions: Pessary; Genital Prolapse; Satisfaction

Treatments: Device: pessary use

Study type: Observational

Funder types: Other

Identifiers

NCT03615872

2018-A00004-51

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)