Underactive BladderNCT06956209
Akyva First In Human
A study testing Direct Bladder Wall Stimulation in people with Underactive Bladder, run by Iota Biosciences, Inc at 2 sites in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Underactive Bladder
- What is being tested?
- Direct Bladder Wall Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesAustralia
- Study dates
- 24 Sep 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are male or female, as assigned at birth, aged ≥ 22 years of age. (SCI Only: 22 to 70 years of age)
- Able to initiate at least three (3) volitional voiding episodes over the 7-day period based on review of their 7-day bladder diary collected between day of consent and before the implant procedure.
- Currently performing clean intermittent catheterization (CIC) for urinary retention at a rate of ≥7 catheterization episodes over the 7-day period, as reflected in a 7-day bladder diary collected between day of consent and before the implant procedure.
- Are medically fit to withstand abdominal-pelvic surgery under general anesthesia, as evaluated by standard-of-care pre-operative surgical clearance.
- Females of childbearing potential must agree to the use of contraception for the duration of the study
- Are able to understand the risks associated with the study, are willing and able to provide written informed consent prior to any study-related activity, willing and capable of participating in all follow up assessments and willing to undergo all study assessments as described at an approved clinical investigator site.
- No neurologic cause
- SCI Only: Chronic spinal cord injury (>= 6 months post-injury) with sacral/infrasacral (L1 or below) lesions, or mixed lesions associated with neurogenic lower urinary tract dysfunction (NLUTD).
Who cannot join
- Have or are scheduled for implant of any active implantable medical device (e.g., pacemaker or intrathecal or infusion pump). Individuals with implanted but inactive SNM may participate. Individuals with implanted and inactive SNM devices may participate.
- Have metallic implants/fragments within 2 cm of the Lead paddles.
- Have a documented allergy to tissue contacting Akyva System materials: tecothane, titanium, silicone, epoxy, stainless steel, nickel/cobalt/chromium/molybdenum, polyether ether ketone (PEEK), platinum, iridium, polymethylpentene (TPX), polycarbonate, polyester.
- In the opinion of the Investigator(s), participants who need or are likely to need magnetic resonance imaging (MRI) as part of their routine care for the duration of the study. If MRI is clinically indicated, during or after the study, explant of the Akyva System may be required
- Have active infection requiring treatment with antibiotics at Screening, unless cleared before Akyva System Surgical Implant (Visit 2).
- Previous or planned major surgical procedures, including, but not exclusive to: prior mesh implant < 3 years old, OR history of mesh-related complications (e.g. erosion, exposure, infection, chronic pain), augmentation cystoplasty, urinary diversion, bladder reconstruction, and any other procedure that increases the risk of device implantation.
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- Active medical conditions that could increase the risk of surgery or device implantation, including, but not exclusive to: ascites, severe inflammatory diseases, bleeding or clotting disorders, severe cardiopulmonary disease, etc.
- Have a significant clinical finding that would, in the opinion of the Surgical Co-Investigator, increase the risk associated with the implant procedure (e.g. ascites, severe inflammatory disease, bleeding or clotting disorder, other interfering devices etc.).
- Have complete urinary retention.
- An acontractile detrusor.
- Any evidence of current bladder outlet obstruction from any cause, including, but not exclusive to, bladder neck stenosis, prostatic hypertrophy, or urethral stricture. Participants with prior surgical treatment of BPH with no clinical evidence of obstruction and do not require routine MRI may be included.
- Type I or Type II diabetes, with an HbA1C ≥ 7.0% within the last 60 days from consent.
- Have documented renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min/1.73 m² or
- Evidence of moderate to severe hydronephrosis (grade 3 or 4 per Society for Fetal Urology [SFU] grading scale) on renal and bladder ultrasound within 60 days prior to implant.
- Have any history of dialysis or kidney transplant.
- Have more than 1 active/symptomatic bladder stone and/or have a bladder stone > 5 mm in size.
- Have a symptomatic kidney stone requiring intervention within the last 12 months, and/or have a kidney stone > 5 mm in size.
- Have any history of bladder cancer.
- Locally advanced or metastatic thoracic, abdominal, or pelvic malignancy other than bladder cancer unless disease-free for five (5) years or greater.
- Have any history of radiation cystitis.
- Have had botulinum toxin injection in the bladder or pelvic floor in the past 6 months measured from the day of consent.
- Diagnosis of overactive bladder (OAB), with urge urinary incontinence (OAB-wet), whether treated or untreated.
- In the opinion of the PI, an iatrogenic cause, e.g., prior pelvic surgery, multiple or complicated deliveries, and/or other potential events are the suspected cause of UAB symptoms.
- Currently using an indwelling (e.g. Foley) catheter for bladder emptying, with an exception for nighttime-only use.
- Currently using suprapubic catheters, unless the suprapubic catheter is removed at least 30 days prior to implant.
- Participants who are unable to discontinue anticoagulant therapy for the implant procedure.
- Females of childbearing potential who are pregnant, not using medical birth control or who are planning to become pregnant during the anticipated study period.
- Predicted life expectancy of less than two years from the day of consent.
- Any condition that, in the Investigator's opinion, would preclude participation in the study (e.g., have a medical condition that may interfere with interpretation of study results, inability to adhere to the visit schedule, poor cognitive abilities, poor compliance with treatment regimen, or poor dexterity to use the system etc.).
- Previously (within 5.5x the terminal half-life (drug trial) or 8 weeks (device trial) of the screening visit) or currently enrolled in another investigational drug or device trial that targets lower urinary tract symptoms/function.
- Vulnerable persons such as prisoners, mentally-disabled or cognitively impaired, homeless or economically disadvantaged, nursing home patients, or others requiring legally authorized representatives.
- Participants that work in an environment with exposures to high levels of electromagnetic interference such as working with high powered electrical equipment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Australian Prostate Centre
Melbourne N., Victoria, 3051
Rachel Heerey, +61 3 8373 7600, Rachel.Heerey@apcr.org.au
Paul Anderson, MD
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Wan-Yi Jiang, +610731764271, wanyi.jiang@health.qld.gov.au
Eric Chung
About this study
Official title: A First-in-Human, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of an Implantable Device for Direct Bladder Wall Stimulation in Participants With Lower Urinary Tract Symptoms of Underactive Bladder
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
- Underactive Bladder
- Being tested
- Direct Bladder Wall Stimulation
- Keywords
- Underactive Bladder
- Medical subject headings
- Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Bladder Wall StimulationDevice
The Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination
| Study group | Role | What they receive |
|---|---|---|
| Akyva System | Experimental | Participants in the study arm will receive a device called the "Akyva System." The Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination. Both non-neurogenic and spinal cord injury neurogenic underactive bladder patients will be included. Receives: Device: Direct Bladder Wall Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety of implantation and use of the Akyva System
Justification of Endpoint: As this is a first-in-human study, the primary objective is to assess the safety of the implantation and use of the Akyva System for bladder wall stimulation.
Treatment-emergent incidence rates of ADEs, SADEs, and UADEs
Measured: From enrollment to 6 and 18 months
Secondary outcomes (2)
To assess the effect of bladder wall stimulation on bladder emptying
Justification of Endpoint: This would be assessed by decrease in residual urine/increase in voiding efficiency or decreases in catheter reliance.
- Mean number of daily volitional, satisfactory voiding episodes pre- and post-implant as recorded in the bladder diary over a 3-day or 7-day period
- Mean daily voiding efficiency pre- and post- implant as recorded in the bladder diary over a 3-day or 7-day period
- Mean number of daily catheterizations pre- and post-implant as recorded in the bladder diary over a 3-day or 7-day period
Measured: From enrollment through 18 months
To assess the surgical feasibility of the Akyva system implantation procedure based on clinical usability survey data
Justification of Endpoint: Although the surgical approach to accessing the anterior-lateral bladder wall is common in practice, the placement and use of the Akyva IPG and Leads is unique. This endpoint aims to analyze the feasibility of the Akyva implantation.
- Two Akyva Leads sutured to the anterior-lateral bladder wall connected to the Akyva IPG, and an Akyva systems check demonstrating functionality verified with no non-compliance errors.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start24 Sep 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First in human
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iota Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc, H&A LifeSciences Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Carmela Cusumano, MS, CCRP, CMDA, Study director, Iota BiosciencesMike Woods, MD, Study chair, iota Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956209
- Sponsor's protocol ID
- iota-AS-AUS-001
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of an Implantable Device for Direct Bladder Wall Stimulation in Participants With Lower Urinary Tract Symptoms of Underactive Bladder
- ClinicalTrials.gov ID
- NCT06956209
- Acronym / sponsor ID
- iota-AS-AUS-001
- Conditions
- Underactive Bladder
- Keywords
- Underactive Bladder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Iota Biosciences, IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc, H&A LifeSciences Pty Ltd
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First in human
| Arm | Type | Receives |
|---|---|---|
| Akyva System | Experimental | Device: Direct Bladder Wall StimulationParticipants in the study arm will receive a device called the "Akyva System." The Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination. Both non-neurogenic and spinal cord injury neurogenic underactive bladder patients will be included. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are male or female, as assigned at birth, aged ≥ 22 years of age. (SCI Only: 22 to 70 years of age)
- Able to initiate at least three (3) volitional voiding episodes over the 7-day period based on review of their 7-day bladder diary collected between day of consent and before the implant procedure.
- Currently performing clean intermittent catheterization (CIC) for urinary retention at a rate of ≥7 catheterization episodes over the 7-day period, as reflected in a 7-day bladder diary collected between day of consent and before the implant procedure.
- Are medically fit to withstand abdominal-pelvic surgery under general anesthesia, as evaluated by standard-of-care pre-operative surgical clearance.
- Females of childbearing potential must agree to the use of contraception for the duration of the study
Key exclusion criteria (32 listed)
- Have or are scheduled for implant of any active implantable medical device (e.g., pacemaker or intrathecal or infusion pump). Individuals with implanted but inactive SNM may participate. Individuals with implanted and inactive SNM devices may participate.
- Have metallic implants/fragments within 2 cm of the Lead paddles.
- Have a documented allergy to tissue contacting Akyva System materials: tecothane, titanium, silicone, epoxy, stainless steel, nickel/cobalt/chromium/molybdenum, polyether ether ketone (PEEK), platinum, iridium, polymethylpentene (TPX), polycarbonate, polyester.
- In the opinion of the Investigator(s), participants who need or are likely to need magnetic resonance imaging (MRI) as part of their routine care for the duration of the study. If MRI is clinically indicated, during or after the study, explant of the Akyva System may be required
- Have active infection requiring treatment with antibiotics at Screening, unless cleared before Akyva System Surgical Implant (Visit 2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Bladder Wall StimulationThe Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination | Device | Akyva System |
Primary outcome
To characterize the safety of implantation and use of the Akyva System
Time frame: From enrollment to 6 and 18 months
Justification of Endpoint: As this is a first-in-human study, the primary objective is to assess the safety of the implantation and use of the Akyva System for bladder wall stimulation. Treatment-emergent incidence rates of ADEs, SADEs, and UADEs
2 secondary outcomes
To assess the effect of bladder wall stimulation on bladder emptying
Time frame: From enrollment through 18 months
To assess the surgical feasibility of the Akyva system implantation procedure based on clinical usability survey data
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmela Cusumano, MS, CCRP, CMDA study director
Iota Biosciences
Mike Woods, MD study chair
iota Biosciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Bladder Wall Stimulation in people with Underactive Bladder, run by Iota Biosciences, Inc at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akyva Study Team (+1 925-788-5929, akyvastudy@iota.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the safety of implantation and use of the Akyva System (time frame: From enrollment to 6 and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.