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:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT04731961
Eligibility Criteria:
Inclusion Criteria:
* Females at least 21 years of age
* English speaking
* Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing for self-characterization of incontinence type
* Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary
* Patient or caregiver willing to perform clean intermittent catheterization, or patient willing to have indwelling Foley catheter in the event this would be required
* Request for treatment for urgency urinary incontinence. The patient may have tried other pharmacologic treatments for urge incontinence, such as antispasmodic agents or non-pharmacologic treatments, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
* Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment
* Subject is able to complete all study related items and interviews
* Willingness and ability to comply with scheduled visits and study procedures.
Exclusion Criteria:
* Current symptomatic urinary tract infection that has not resolved prior to randomization.
* Baseline need for intermittent self-catheterization
* PVR (Post void residual) \>150 mL on 2 occasions with void(s) of greater than 150 mL
* Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
* Any prior intra-detrusor botulinum toxin A injections
* Previous or currently implanted neuromodulation (sacral or tibial).
* Surgically altered detrusor muscle, such as augmentation cystoplasty.
* Known allergy to botulinum toxin A.
* Women with known neurologic disease believed to potentially affect urinary function (history of stroke, Parkinson's disease, multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
* Known allergy to lidocaine.
* Currently pregnant or lactating patients or patients planning pregnancy within the next year.
* Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study.
* Cystoscopic findings that preclude injection, in the opinion of the investigator.
* Current or prior bladder malignancy.
* Inability to understand diary instructions and complete 3-day voiding diary.
* Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
* Subjects with hematuria who have not undergone a clinically appropriate evaluation.
* Serum creatinine level greater than twice the upper limit of normal within the previous year.
* Two or more hospitalizations for medical conditions in the previous years
* Plans to move out of area in the next 6 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT04731961
Study Brief:
Protocol Section:
NCT04731961