NCT03615872 Pessary Satisfaction Criteria for Urogenital Prolapse
| NCT ID | NCT03615872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Caen |
| Condition | Genital Prolapse |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2018-06-20 |
| Primary Completion | 2018-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2018-06-20 with a primary completion date of 2018-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Anne Cecile PIZZOFERRATO, MD
PRINCIPAL INVESTIGATOR
Universitary Hospital of Caen
Frequently Asked Questions
Who can join the NCT03615872 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Genital Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03615872 currently recruiting?
Yes, NCT03615872 is actively recruiting participants. Contact the research team at acpizzofe@gmail.com for enrollment information.
Where is the NCT03615872 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT03615872 clinical trial?
NCT03615872 is sponsored by University Hospital, Caen. The principal investigator is Anne Cecile PIZZOFERRATO, MD at Universitary Hospital of Caen. The trial plans to enroll 150 participants.