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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cpt, up to 30 minutes
Awards & highlights
AMPLIFY Trial Summary
This trial will study whether electrical stimulation can decrease urinary symptoms and increase bladder function in women with underactive bladders.
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.Check my eligibility
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.See study design
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.
AMPLIFY Trial 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.
AMPLIFY Trial 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 moreAMPLIFY 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.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,486 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap for participant enrollment in this trial?
"Correct. Clinicaltrials.gov indicates that this research project, which was initially submitted on September 1st 2021 is actively enrolling participants. The protocol requires 20 volunteers from a single location to participate in the study."
Answered by AI
What is the principal aim of this inquiry?
"This pressure-flow study, conducted over a timespan of no more than 30 minutes, aims to gauge the change in discomfort and sensation. Secondary objectives include measuring the contraction strength and duration using intraurethral electrical stimulation; recording bladder pressures throughout voiding; and assessing volumes at cystometric endpoints with intravesical electrical stimulations. Additionally, it is important to determine patients' sensations as well as their urgency when they experience first sensation during bladder filling process up until maximum capacity point."
Answered by AI
Is registration for this trial currently open?
"Affirmative. According to clinicaltrials.gov, this trial is presently open for recruitment and was first announced on September 1st 2021 before being modified more recently on the 26th of September 2022. It requires 20 participants from a single medical facility."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
Duke Medical Plaza Patterson Place
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Chronic urinary retention. Self cath past 6 months.
PatientReceived 1 prior treatment
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