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 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT04516434
Eligibility Criteria:
Inclusion Criteria:
* Females ages 18 and older
* Able to provide informed consent and agree to the study risks
* Willing to withdraw from medications affecting urination for the 48 hours prior to the procedure (e.g., alpha-adrenergic antagonists, cholinergic agonists, cholinesterase inhibitors)
* Has the below response to 2 of the 3 questions:
1. Questions regarding self-reported poor sensation during bladder filling or emptying (one or more of the below)
* In the past 7 days, where did the participant feel sensations when needing to urinate? Answer: "No" response for Bladder Area
* In the past 7 days, how often did the participant have no sensation of urine flow while urinating? Answer: "Most of the time" or "Every time" response
* In the past 7 days, how often did the participant feel that the bladder was not completely empty after urination? Answer: "Most of the time" or "Every time" response
2. Questions regarding self-reported bothersome urinary symptoms (one or more of the below)
* In the past 7 days, how satisfied was the participant with bladder function? Answer: "Not at all satisfied" or "Somewhat satisfied" response
* In the past 7 days, how bothered was the participant by urinary symptoms? Answer: "Very bothered" or "Extremely bothered" response
3. Standard uroflowmetry with a voiding efficiency (voided volume / voided volume + residual volume) of \< 80%, voided volume + residual volume must be \>150ml for measurement
Exclusion Criteria:
* Preexisting neurological impairment (e.g., spinal cord injury, multiple sclerosis, Guillain-Barre, cauda equina syndrome, cerebrovascular accident, Parkinson's disease, traumatic brain injury)
* Functional obstruction demonstrated by either elevated pelvic floor activity on EMG during standard pressure flow study or high tone pelvic floor on clinical exam)
* Pelvic organ prolapse beyond introitus
* Active urinary tract infection (candidate would be deferred until treated)
* Positive pregnancy test
* Less than 6 weeks postpartum
* Unevaluated hematuria
* Urethral stricture/stenosis
* Surgical obstruction i.e., urinary retention due to obstructive sling or other anti incontinence procedure
* Surgical procedures to increase bladder capacity (e.g., augmentation cystoplasty)
* Active sacral neuromodulation or ongoing posterior tibial nerve stimulation sessions
* Botulinum toxin injection in the past six months
* History of genitourinary or gastrointestinal cancer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04516434
Study Brief:
Protocol Section:
NCT04516434