Actively Recruiting
Akyva First In Human
Led by Iota Biosciences, Inc · Updated on 2026-02-09
15
Participants Needed
2
Research Sites
153 weeks
Total Duration
On this page
Sponsors
I
Iota Biosciences, Inc
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to check if the study device, the Akyva System, is safe to use and to find out if it has any possible side effects. Researchers will see if the study device can help you urinate without the need for catheterization, which involves passing a catheter (small tube) into the bladder, and if there is improvement in the leftover urine amount in your bladder after urinating or trying to urinate.
CONDITIONS
Official Title
Akyva First In Human
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, assigned at birth, aged 22 years or older
- Have lower urinary tract symptoms ongoing for at least 90 days before consent
- Currently perform clean intermittent catheterization at a rate of 3 or more times per day
- Have a post-void residual urine volume of 300 mL or more measured at least twice within 180 days before screening
- Have a history of recurrent urinary tract infections with at least two episodes in the past 180 days or are managing recurrent UTIs with antibiotics
- Have urodynamic measurements indicating detrusor underactivity, including bladder contractility index below 100 in males or Qmax below 15 mL/s and PdetQmax below 20 cmH2O in males or females
- Medically fit for abdominal-pelvic surgery under general anesthesia as cleared by standard pre-operative evaluation
- Females of childbearing potential agree to use contraception for the study duration
- Able to understand risks, provide informed consent, and participate in all study assessments
- For neurogenic participants only: have chronic spinal cord injury (6 months or more post-injury) with sacral or infrasacral lesions or mixed lesions causing neurogenic lower urinary tract dysfunction
You will not qualify if you...
- Have or plan to receive any active implantable medical device or have metallic implants/fragments in abdomen or pelvis, except certain sacral neuromodulation devices
- Have allergy to materials contacting the Akyva System such as titanium, silicone, nickel, or others listed
- Require or likely to require MRI during study duration
- Have hypersensitivity to iodine-containing contrast dyes or history of severe allergy with anaphylaxis
- Have active infection needing antibiotics at screening unless cleared before implant
- Have history of major pelvic or abdominal surgery increasing risk of implant injury
- Have history or planned genitourinary reconstruction surgery within 24 months
- Have clinical conditions increasing implant risk such as ascites, severe inflammation, bleeding or clotting disorders
- Have poorly controlled diabetes with HbA1C of 7.0% or higher
- Have kidney dysfunction with eGFR 50 mL/min/1.73 m2 or less, or history of dialysis or kidney transplant
- Have history of kidney or bladder stones within 5 years
- Have history of bladder or pelvic cancer unless disease-free for 2 or more years
- Have history of radiation cystitis or recent malignancy except treated and cured
- Non-neurogenic only: have had botulinum toxin injection in bladder or pelvic floor within 6 months
- Have history of major bladder reconstructive surgeries
- Have bladder compliance less than 20 mL/cmH2O
- Non-neurogenic only: have current neurogenic bladder diagnosis
- Have any history or symptoms of overactive bladder
- Non-neurogenic only: have iatrogenic cause of underactive bladder symptoms
- Currently use indwelling catheters except nighttime only
- Use suprapubic catheters unless removed 30 days before implant
- Females with prior abdominal sacrocolpopexy for pelvic prolapse
- Males with elevated PSA or prostate cancer under evaluation or treatment
- Unable to stop anticoagulant therapy for implant procedure
- Females of childbearing potential who are pregnant, not using birth control, or planning pregnancy during study
- Life expectancy less than one year
- History of bladder outlet obstruction due to bladder neck stenosis, BPH or urethral stricture, unless treated without obstruction
- Any condition interfering with participation or study interpretation
- Currently or recently (within 8 weeks) enrolled in other investigational drug or device trials
- Vulnerable persons such as prisoners, cognitively impaired, homeless, nursing home residents, or needing legal representatives
- Work involving high levels of electromagnetic interference
- Neurogenic only: history of sphincterotomies or untreated overactive bladder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Not Yet Recruiting
2
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
Research Team
A
Akyva Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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