What side effects are associated with this type of intervention?

Common treatments for Underactive Bladder (UAB) include intravesical and intraurethral electrical stimulation, which aim to enhance bladder muscle activity and improve voiding efficiency. Known side effects of these electrical stimulation therapies can include discomfort or pain at the site of stimulation, urinary tract infections, and transient hematuria (blood in the urine). Additionally, patients may experience bladder spasms or increased urgency. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of the treatment.

What prior FDA approvals exist?

There is limited specific information available regarding FDA approvals for treatments of Underactive Bladder that are similar to Intravesical and Intraurethral Electrical Stimulation. However, electrical stimulation therapies, such as sacral neuromodulation, have been approved by the FDA for other bladder dysfunctions, including overactive bladder and urinary retention. These therapies aim to enhance bladder muscle activity and improve voiding efficiency, which aligns with the goals of the treatments being studied in the trial.

What other types of research exist?

Promising novel alternatives to intravesical and intraurethral electrical stimulation for underactive bladder patients include: 1) Sacral Neuromodulation (SNM) - involves electrical stimulation of the sacral nerves to improve bladder function. 2) Percutaneous Tibial Nerve Stimulation (PTNS) - a minimally invasive procedure that stimulates the tibial nerve to enhance bladder control. 3) Spinal Cord Stimulation (SCS) - although primarily used for pain management, it has shown potential in improving bladder function by modulating neural pathways. These alternatives offer different mechanisms of action and may provide effective treatment options for UAB patients.

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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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ cpt, up to 30 minutes

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

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 more

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

Cystometry

2022

N/A

~40

0 / 11Eligibility criteria met

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.