Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University Hospital, Caen
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary
Time Frame: 1 year
The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments
Secondary Outcomes
- INVESTIGATE the impact of menopausal status on the removal or expulsion of pessary(1 year to 5 years)
- INVESTIGATE the impact of weight on the removal or expulsion of pessary(1 year to 5 years)
- INVESTIGATE the impact of hysterectomy history on the removal or expulsion of pessary(1 year 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.(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.(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)(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(at 1 year, then every year for 5 years)
- Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) every year for five years after the installation of a pessary(1 to 5 years)
- INVESTIGATE the impact of age 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(1 year to 5 years)
- INVESTIGATE the impact of the prolapse stage of on the removal or expulsion of pessary(1 year to 5 years)
- Complications of pessary use reported by their rate(1 to 5 years)