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Electrical Stimulation
Electrical Stimulation for Underactive Bladder (AMPLIFY Trial)
N/A
Recruiting
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
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 belowSelect...
I often feel no urine flow when I try to urinate.
Select...
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:Select...
I have had surgery to increase my bladder size.
Select...
I am currently undergoing sacral neuromodulation or posterior tibial nerve stimulation therapy.
Select...
I have received a botulinum toxin injection in the last 6 months.
Select...
I have had cancer in my urinary or digestive system.
Select...
I have urinary retention due to a previous surgery for incontinence.
Select...
I have a narrowed urethra.
Select...
I have a preexisting condition affecting my nervous system.
Select...
My pelvic organs have dropped and bulge outside my vagina.
Select...
My tests show I have a tight pelvic floor causing blockage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cpt, up to 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cpt, up to 30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Bothersome Symptoms and Sensation
Voided Percentage
Secondary outcome measures
Bladder Contraction Duration
Bladder Contraction Strength
Current Perception Threshold
+1 moreTrial 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
Cystometry
2022
N/A
~40
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.
Electrical stimulation for neuroregeneration in urology: a new therapeutic paradigm.
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,066,064 Total Patients Enrolled
Em Abbott, PhDPrincipal InvestigatorDuke University
Cindy L Amundsen, MDStudy ChairDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to increase my bladder size.I have received a botulinum toxin injection in the last 6 months.You are pregnant.I am currently undergoing sacral neuromodulation or posterior tibial nerve stimulation therapy.You have not been checked for blood in your urine.I have had cancer in my urinary or digestive system.I have urinary retention due to a previous surgery for incontinence.Your urine flow test showed that you don't empty your bladder completely or have a small amount of urine left after going to the bathroom.I have a narrowed urethra.I can stop taking any medication that affects urination 2 days before the procedure.You have experienced problems with feeling your bladder filling or emptying when asked about it.You gave birth less than 6 weeks ago.I have been very or extremely bothered by urinary symptoms in the last week.I often feel no urine flow when I try to urinate.I experience bothersome urinary symptoms.I have a preexisting condition affecting my nervous system.I experience troubling urinary symptoms.My pelvic organs have dropped and bulge outside my vagina.I have trouble feeling when my bladder is full or when I am emptying it.I often feel my bladder isn’t completely empty after I urinate.I am a woman aged 18 or older.I do not currently have an active urinary tract infection.My tests show I have a tight pelvic floor causing blockage.
Research Study Groups:
This trial has the following groups:- Group 1: Intravesical Electrical Stimulation
- Group 2: Intraurethral Electrical Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Underactive Bladder Patient Testimony for trial: Trial Name: NCT04516434 — N/A
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