N/A
N=20
Amplifying Sensation in Underactive Bladder
Urinary Bladder, Underactive
Bottom Line
View on ClinicalTrials.gov: NCT04516434 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Voiding Efficiency — 32; 53; 43; 46 voided percentage — p=1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neurometer Neurotron CPT (Device); Cystometry (Procedure); Pressure-flow study (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Voiding Efficiency |
32; 53; 43; 46 | 1 |
| PRIMARY Change in Bothersome Symptoms and Sensation |
52; 53; 46; 39 | 0.08 |
| SECONDARY Current Perception Threshold |
8.57; 8.27; 9.99; 9.04; 9.99; 9.99 | — |
| SECONDARY Cystometry Volume |
290; 253; 281; 357; 517; 458 | 1 |
| SECONDARY Bladder Contraction Strength |
11; 33; 21; 25 | 1 |
| SECONDARY Bladder Contraction Duration |
8; 15; 15; 13 | 1 |
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 neurologically-intact adult women with underactive bladder. The investigators hypothesize that electrical stimulation will decrease bothersome urinary symptoms relative to baseline and increase voided percentage during pressure-flow studies compared to their routine clinical exam.
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:
- 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 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
Data sourced from ClinicalTrials.gov (NCT04516434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.