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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT04807920
Eligibility Criteria:
Inclusion Criteria:
* Women scheduled for prolapse surgery
* Bothersome OAB symptoms determined by a score of \>20 on the OAB-q SF
* Willingness to perform clean intermittent catheterization (CIC)
* Ability to follow study instructions and complete required follow up
Exclusion Criteria:
* Contraindications or allergy to Onabotulinumtoxin A
* Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date
* Total body Onabotulinumtoxin A dose of ≥ 400 Units in the 3 months prior to the scheduled surgery date.
* Inability or unwillingness to self-catheterize
* Post-void residual ≥ 200mL
* Neurogenic bladder or other neurological diseases that may cause voiding dysfunction
* Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery.
* Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study.
* Inability to speak or read English
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04807920
Study Brief:
Protocol Section:
NCT04807920