What is the Akyva System studying for underactive bladder?

The Akyva System is being studied to evaluate its safety and ability to help improve bladder emptying in people with underactive bladder. Researchers want to see if the device can reduce the need for catheterization and lower leftover urine after urination. The study is sponsored by Iota Biosciences, Inc.

Who may be eligible for this underactive bladder clinical trial?

Adults aged 22 years and older with underactive bladder, including those with spinal cord injury, may be eligible. Participants must be able to urinate voluntarily several times a week and currently use clean intermittent catheterization. They should be medically fit for surgery and able to follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this underactive bladder clinical trial?

Study-related care, including the device implantation and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 22Years +

All Genders

ID06956209

First Human Study of the Akyva System Device to Electrically Stimulate the Bladder Muscle for Treating Underactive Bladder Symptoms

Led by Iota Biosciences, Inc · Updated on 2026-06-15

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the Akyva System, an implantable device designed to electrically stimulate the bladder muscle to help people with underactive bladder symptoms. The study aims to evaluate the safety of this device and observe any possible side effects. This research includes adults with non-neurogenic or spinal cord injury-related underactive bladder and investigates if the device can improve bladder emptying and reduce leftover urine after urination. Participants will receive the Akyva System implanted through surgery. The device targets the bladder muscle that controls urination by electrical stimulation. The study includes both non-neurogenic and neurogenic underactive bladder patients. The surgical feasibility of implanting the device will also be assessed. This is a single-group interventional trial evaluating the devices effect and safety over time. During the study, participants will be monitored from enrollment through 18 months. Researchers will assess safety related to device implantation and use, bladder emptying effectiveness, and surgical usability. Participants will be followed with bladder diaries, clinical evaluations, and safety assessments. The study involves pre-operative evaluation, device implantation, and multiple follow-up visits to measure outcomes and monitor for any adverse events.

CONDITIONS

Brief Title

Akyva First In Human

Who Can Participate

Age: 22Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female, as assigned at birth, aged 22 years or older (22 to 70 years for spinal cord injury participants)
Ability to voluntarily urinate at least three times over a 7-day period based on a bladder diary
Currently performing clean intermittent catheterization at least seven times over a 7-day period
Medically fit for abdominal-pelvic surgery under general anesthesia as assessed by standard pre-operative clearance
Females of childbearing potential must agree to use contraception for the study duration
Willing and able to provide informed consent and participate in all study assessments
No neurologic cause of underactive bladder (except for spinal cord injury participants with lesions at L1 or below or mixed lesions with neurogenic lower urinary tract dysfunction for at least 6 months)

You will not qualify if you...

Have or plan to have any active implantable medical device (e.g., pacemaker or infusion pump), except inactive sacral neuromodulation devices
Have metallic implants or fragments in the abdomen or pelvis
Allergic to materials contacting the Akyva System device
Likely to need MRI during the study period
Active infection requiring antibiotics at screening unless cleared before implantation
Previous or planned major urological surgeries that increase implant risk
Active medical conditions increasing surgery risk (e.g., bleeding disorders, severe cardiopulmonary disease)
Complete urinary retention or acontractile detrusor
Bladder outlet obstruction or related conditions
Diabetes with recent HbA1C ≥ 7.0%
Renal dysfunction or history of dialysis or transplant
Recent history of kidney or bladder stones or bladder cancer
Recent botulinum toxin injections in bladder or pelvic floor
Diagnosis of overactive bladder with urge incontinence
Use of indwelling or suprapubic catheters without required removal time
Unable to discontinue anticoagulants for surgery
Pregnant or planning pregnancy without medical birth control
Life expectancy less than two years
Any condition that may interfere with study participation or results
Recent or current enrollment in other investigational trials targeting lower urinary tract
Vulnerable populations such as prisoners or cognitively impaired
Work exposure to high electromagnetic interference environments

Research Team

Akyva Study Team

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First Human Study of the Akyva System Device to Electrically Stimulate the Bladder Muscle for Treating Underactive Bladder Symptoms

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria