Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT02239133
Eligibility Criteria:
Inclusion Criteria:
* Females aged 21-80 years
* Ability to use both hands and insert a device into the vagina
* Ability to attend the study site as explained by the investigator
* A symptomatic sensation of vaginal prolapse
* The subject has the ability to understand the nature of the study and sign the informed consent
* On examination, the presence of a vaginal wall prolapse of one or more sites
* On examination, POP-Q grade 2 - 4 POP is demonstrated
* A 61-91 mm pessary is well fitted
* A 61-91 mm pessary is well retained
Exclusion Criteria:
* Previous inability to accommodate with tampons or vaginal pessaries
* Subject is currently participating in another clinical study which may directly or indirectly affect the results of this study
* Co-morbid condition(s) or severe systemic disease that could limit the subject 's ability to participate in the study, or impact the scientific integrity of the study
* Subject is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study
* Abnormal vaginal bleeding in the past 6 months
* Previous vaginal surgery during the last 3 months
* A severely atrophic vagina
* Existing vaginal or vulvar laceration
* Symptomatic vaginal infection as determined by physical examination and lab results
* Symptomatic urinary tract infection as determined by physical examination and lab results
* Recurrent urinary tract infections
* Abnormal cervical cytology
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02239133
Study Brief:
Protocol Section:
NCT02239133