Genital Prolapse, Pessary, Satisfaction
Conditions
Keywords
quality of life, efficiency
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
Interventions
DEVICEpessary use
evaluation of satisfaction of pessary use in case of symptomatic genital prolapse
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary | 1 year | The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The PFIQ-7 was developped to evaluate the impact of the symptoms on the quality of life |
| 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 | The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments |
| 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 | This score was developped to evaluate the genital, anorectal and urinary symptoms related to genital prolapse |
| 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 | These scores are self-questionnaires specifically validated to evaluate urinary incontinence and urinary tract dysfunctions |
| 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 | 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 |
| INVESTIGATE the impact of age on the removal or expulsion of pessary | 1 year to 5 years | Impact of age (years) on treatment failure (removal or expulsion of pessary) |
| INVESTIGATE the impact of weight on the removal or expulsion of pessary | 1 year to 5 years | Impact of weight (Kg) on treatment failure (removal or expulsion of pessary) |
| INVESTIGATE the impact of hysterectomy history on the removal or expulsion of pessary | 1 year to 5 years | Impact of hysterectomy history (yes/no) on the removal or expulsion of pessary |
| INVESTIGATE the impact of prolapse surgery history on the removal or expulsion of pessary | 1 year to 5 years | Impact of prolapse surgery history (yes/no) on the removal or expulsion of pessary |
| INVESTIGATE the impact of the prolapse stage of on the removal or expulsion of pessary | 1 year to 5 years | 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 |
| Complications of pessary use reported by their rate | 1 to 5 years | Rate of complications related to the use of a pessary (frequencies) |
| INVESTIGATE the impact of menopausal status on the removal or expulsion of pessary | 1 year to 5 years | Impact of menopausal status (yes/no) on treatment failure (removal or expulsion of pessary) |
Countries
France
Contacts
Primary ContactAnne Cecile PIZZOFERRATO, MD
Backup ContactAnne VILLOT, MD
Outcome results
None listed