Status:
COMPLETED
Amplifying Sensation in Underactive Bladder
Lead Sponsor:
Duke University
Conditions:
Urinary Bladder, Underactive
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the influence of intravesical (bladder) electrical stimulation and intraurethral electrical stimulation on bothersome symptoms and bladder function in neurolo...
Detailed Description
1. Objective: The overall objective of this study is to improve lower urinary tract symptoms (LUTS) in adult neurologically-intact women with underactive bladder through electrical stimulation of blad...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
- Standard uroflowmetry with a voiding efficiency (voided volume / voided volume + residual volume) of \< 80%, voided volume + residual volume must be \>150ml for measurement
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04516434
Start Date
September 1 2021
End Date
September 27 2024
Last Update
July 16 2025
Active Locations (1)
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1
Duke Medical Plaza Patterson Place
Durham, North Carolina, United States, 27707