Akyva First In Human

NCT06956209 | Recruiting DMC FDA Device

• 1 other identifier: iota-AS-AUS-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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 is improvement in the leftover urine amount in your bladder after urinating or trying to urinate.

Conditions

Underactive Bladder

Keywords

Underactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to 6 and 18 months

Secondary Outcomes (2)

• To assess the effect of bladder wall stimulation on bladder emptying

  From enrollment through 18 months

• To assess the surgical feasibility of the Akyva system implantation procedure based on clinical usability survey data

  Perioperative/Periprocedural

Study Arms (1)

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.

Device: Direct Bladder Wall Stimulation

Interventions

Direct Bladder Wall Stimulation DEVICE

The Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination

Akyva System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 in the abdomen or pelvis (e.g., piercings or hip replacement).
• 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, augmentation cystoplasty, urinary diversion, bladder reconstruction, sacrocolpopexy, and any other procedure that increases the risk of device implantation.
• 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.

Sponsors & Collaborators

• Iota Biosciences, Inc: lead
• Astellas Pharma Inc: collaborator
• H&A LifeSciences Pty Ltd: collaborator

Study Sites (2)

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Australian Prostate Centre

Melbourne N., Victoria, 3051, Australia

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmela Cusumano, MS, CCRP, CMDA

  Iota Biosciences

  STUDY DIRECTOR

• Mike Woods, MD

  iota Biosciences

  STUDY CHAIR

Central Study Contacts

Akyva Study Team

CONTACT

+1 925-788-5929; akyvastudy@iota.bio

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First in human

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 4, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

AU (2)