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Electrical Stimulation

Electrical Stimulation for Underactive Bladder (AMPLIFY Trial)

N/A
Waitlist Available
Led By Em Abbott, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Surgical procedures to increase bladder capacity (e.g., augmentation cystoplasty)
Active sacral neuromodulation or ongoing posterior tibial nerve stimulation sessions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cpt, up to 30 minutes
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from electrical stimulation, urinary tract infections from instrumentation, and possible skin irritation at the site of electrode placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I often feel no urine flow when I try to urinate.
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I often feel my bladder isn’t completely empty after I urinate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to increase my bladder size.
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I am currently undergoing sacral neuromodulation or posterior tibial nerve stimulation therapy.
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I have received a botulinum toxin injection in the last 6 months.
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I have had cancer in my urinary or digestive system.
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I have urinary retention due to a previous surgery for incontinence.
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I have a narrowed urethra.
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I have a preexisting condition affecting my nervous system.
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My pelvic organs have dropped and bulge outside my vagina.
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My tests show I have a tight pelvic floor causing blockage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cpt, up to 30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and cpt, up to 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Bothersome Symptoms and Sensation
Voided Percentage
Secondary study objectives
Bladder Contraction Duration
Bladder Contraction Strength
Current Perception Threshold
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pressure-flow study
2021
N/A
~20
Cystometry
2022
N/A
~60
Neurometer Neurotron CPT
2021
N/A
~20

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Underactive Bladder (UAB) include electrical stimulation methods such as intravesical and intraurethral electrical stimulation. These treatments work by delivering electrical impulses to the bladder and urethral muscles, which can enhance muscle activity and improve the efficiency of voiding. This is particularly important for UAB patients as it can help reduce bothersome urinary symptoms and increase the percentage of bladder emptying, thereby improving overall bladder function and quality of life.
Electrical stimulation for neuroregeneration in urology: a new therapeutic paradigm.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,885 Total Patients Enrolled
Em Abbott, PhDPrincipal InvestigatorDuke University
Cindy L Amundsen, MDStudy ChairDuke University
Eric J Gonzalez, PhDPrincipal InvestigatorDuke University

Media Library

Electrical Stimulation (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04516434 — N/A
Underactive Bladder Research Study Groups: Intravesical Electrical Stimulation, Intraurethral Electrical Stimulation
Underactive Bladder Clinical Trial 2023: Electrical Stimulation Highlights & Side Effects. Trial Name: NCT04516434 — N/A
Electrical Stimulation (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04516434 — N/A
Underactive Bladder Patient Testimony for trial: Trial Name: NCT04516434 — N/A
~5 spots leftby Dec 2025