Pessary Satisfaction Criteria for Urogenital Prolapse

• Conditions: Satisfaction; Genital Prolapse; Pessary

• Registration Number: NCT03615872
• Lead Sponsor: University Hospital, Caen

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 Timeline

• Study Start: 2018-06-20
• Primary Completion: 2018-06-20
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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
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
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
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 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)

Trial Locations

Locations (1)

Pizzoferato; 🇫🇷 Caen, France