Amplifying Sensation in Underactive Bladder (AMPLIFY)
Urinary Bladder, Underactive
About this trial
This is an interventional basic science trial for Urinary Bladder, Underactive focused on measuring electrical stimulation, urodynamics, bladder, urethra
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 < 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
Sites / Locations
- Duke Medical Plaza Patterson PlaceRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Intraurethral Electrical Stimulation
Intravesical Electrical Stimulation
This procedure is specific to the urethral stimulation arm. A sterile stimulation catheter (custom, 7-French) will be placed in the urethra and positioned with the electrode contact 10-14 mm from the bladder neck to stimulate the proximal urethra. A single return electrode will also be placed on the abdominal skin above the pubic bone. Stimuli will be delivered as 0.2 ms charge-balanced biphasic rectangular current pulses. Stimulation frequency will be 2-20 Hz and amplitude will be adjusted individually to 80% of the maximum tolerable intensity. Electrical stimulation will be applied to the proximal urethra at "strong desire to void" during cystometry. The participant will then be given permission to void at "maximum cystometric capacity" with continuous intraurethral stimulation.
This procedure is specific to the bladder stimulation arm. A sterile stimulation catheter (custom, 7-French) will be placed in the bladder through the urethra and the electrode contacts will be positioned to be floating within the bladder. A single return electrode will also be placed on the abdominal skin above the pubic bone. Stimuli will be delivered as 0.2 ms charge-balanced biphasic rectangular current pulses. Stimulation frequency will be set at 20 Hz and amplitude will be adjusted individually to 80% of the maximum tolerable intensity. Electrical stimulation will be applied to bladder sensory nerves for up to 60 minutes prior to the start of urodynamic studies.