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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT04733560
Eligibility Criteria:
Inclusion Criteria:
* Over 18 years of age
* Diagnosed with prolapse and planning to undergo vaginal day surgery as treatment.
* Must be undergoing a sacrospinous ligament fixation as part of their procedure. Those undergoing a concurrent anterior and/or posterior vaginal repair, or mid-urethral sling will also be included.
* Able to read and write in English
* Able to complete email surveys for the first 2 weeks after surgery
Exclusion Criteria:
* Those with an allergy to local anesthetic (freezing injections)
* Those who prefer to have surgery under spinal anesthesia
* Those with planned concurrent vulvar, laparoscopic or abdominal surgery, or any planned concurrent vaginal surgery other than those in the inclusion criteria.
* Those with a pre-existing chronic pain disorder requiring the regular use of opioid analgesics (more than twice weekly)
* Those with a history of substance abuse
* Those with a history of bleeding disorder
* Those who would prefer not to participate in the study,
* If unable to receive emails in order to fill out the surveys.
* Inability to provide informed consent
* Currently enrolled in any other research study involving drugs or devices
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT04733560
Study Brief:
Protocol Section:
NCT04733560