Electrical Stimulation for Underactive Bladder (AMPLIFY Trial)
Palo Alto (17 mi)Overseen byEm Abbott, PhD
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: Duke University
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses mild electrical currents applied to the bladder or urethra to help women with underactive bladder. The goal is to improve their ability to empty their bladder and reduce symptoms like frequent urination and slow urine stream. The treatment works by activating nerves to enhance bladder function. Electrical stimulation has been used historically to treat bladder dysfunction by activating nerves to improve bladder control and function.
Eligibility Criteria
This trial is for neurologically-intact adult women with underactive bladder who often have no sensation of urine flow or feel their bladder isn't completely empty after urination. Participants must be very bothered by these symptoms, able to stop certain medications before the procedure, and provide informed consent.Inclusion Criteria
I often feel no urine flow when I try to urinate.
I often feel my bladder isnβt completely empty after I urinate.
Exclusion Criteria
I have had surgery to increase my bladder size.
I am currently undergoing sacral neuromodulation or posterior tibial nerve stimulation therapy.
I have received a botulinum toxin injection in the last 6 months.
I have had cancer in my urinary or digestive system.
I have urinary retention due to a previous surgery for incontinence.
I have a narrowed urethra.
I have a preexisting condition affecting my nervous system.
My pelvic organs have dropped and bulge outside my vagina.
My tests show I have a tight pelvic floor causing blockage.
Treatment Details
The study tests if intravesical (inside the bladder) or intraurethral electrical stimulation can improve bothersome urinary symptoms and bladder function in women with underactive bladders compared to their usual clinical exams.
2Treatment groups
Experimental Treatment
Group I: Intravesical Electrical StimulationExperimental Treatment3 Interventions
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.
Group II: Intraurethral Electrical StimulationExperimental Treatment3 Interventions
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.
Electrical Stimulation is already approved in United States, European Union, Canada for the following indications:
πΊπΈ Approved in United States as Electrical Stimulation for:
- Pain relief
- Muscle strengthening
- Rehabilitation after injury or surgery
- Neurological disorders
- Wound healing
πͺπΊ Approved in European Union as Electrical Stimulation for:
- Pain management
- Muscle rehabilitation
- Neurological conditions
- Wound care
π¨π¦ Approved in Canada as Electrical Stimulation for:
- Chronic pain
- Muscle atrophy
- Neurological rehabilitation
- Wound healing
Find a clinic near you
Research locations nearbySelect from list below to view details:
Duke Medical Plaza Patterson PlaceDurham, NC
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Who is running the clinical trial?
Duke UniversityLead Sponsor