Assessing patient satisfaction with pessaries for genital prolapse
Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse
This study is trying to see how satisfied women are with using pessaries to manage their genital prolapse symptoms over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT03615872 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the satisfaction of patients using pessaries for symptomatic genital prolapse over a five-year period. Conducted at the University Hospital of Caen, participants will complete validated questionnaires assessing symptoms, sexuality, quality of life, and overall satisfaction at multiple time points: before pessary installation, one month later, at six months, and annually thereafter. The study seeks to provide insights into the effectiveness and patient experience associated with pessary use.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with symptomatic genital prolapse who speak French and consent to participate.
Not a fit: Patients who are minors, pregnant, lactating, or unable to understand French due to cognitive impairments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of patient satisfaction and improve management strategies for genital prolapse.
How similar studies have performed: While there is existing literature on pessary satisfaction, this study's specific focus on longitudinal assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Caen
- Pizzoferato — Caen, France (Recruiting)
Study contacts
- Principal investigator: Anne Cecile PIZZOFERRATO, MD — Universitary Hospital of Caen
- Study coordinator: Anne Cecile PIZZOFERRATO, MD
- Email: acpizzofe@gmail.com
- Phone: +33231272723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.