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 (2)

• 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. o Treatment-emergent incidence rates of AEs, ADEs, SAEs, SADEs, and UADEs that are procedure- or device-related

  From enrollment to the end of the treatment at 18 months

• 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. o No ≥ 20% decrease in eGFR from baseline.

  From enrollment to the end of the treatment at 18 months

Secondary Outcomes (2)

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

  From enrollment to the end of the treatment at 18 months

• To assess the surgical feasibility of the Akyva system implantation procedure

  From enrollment to the end of the treatment at 18 months

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

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 - 70 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.
• Presents lower urinary tract (LUT) symptoms that have been ongoing for at least the past 90 days prior to consent.
• Is currently performing clean intermittent catheterization (CIC) for urinary retention at a rate of ≥3 catheterizations per day, as reflected in a 3-day self-catheterization record taken within 180 days prior to consent or a 7-day self-catheterization record collected between day of consent and before the implant procedure.
• Have a post-void residual (PVR) volume ≥ 300 mL as evaluated at least twice within 180 days prior to screening or during screening. NOTE: Individuals unable to void any volume without catheter assistance, i.e. complete retention, are considered to have a PVR equivalent to pre-catheterization volume.
• Have prior history of recurrent urinary tract infection (UTI) with at least two episodes of infection in the past 180 days or currently managing recurrent UTIs with antibiotic medication (e.g. Hiprex).
• Urodynamic measurements consistent with detrusor underactivity. NOTE: Urodynamics performed within the last 365 days prior to consent are acceptable. (1) Bladder contractility index (BCI) \< 100 (in Males) (2) Qmax \< 15 mL/s and PdetQmax \< 20 cmH2O (in Males or Females).
• 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.
• Neurogenic Only: Chronic spinal cord injury (\>= 6 months post-injury) with sacral/infrascaral (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) or have metallic implants/fragments in the abdomen or pelvis (e.g., piercings or hip replacement). Individuals with fully explanted sacral neuromodulation (SNM) or other implantable medical devices may participate. Individuals with implanted and inactive SNM devices may participate.
• 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 hypersensitivity reaction (Types I-IV) to iodine-containing radiographic contrast dyes, or any documented prior severe allergy resulting in anaphylaxis/intubation.
• Have active infection requiring treatment with antibiotics at Screening, unless cleared before Akyva System Surgical Implant (Visit 2).
• Have any history of prior major pelvic or abdominal surgery that would, in the opinion of the Surgical Co-Investigator, increase the risk of injury to abdominal or pelvic organs during the implant procedure.
• Have any history of genitourinary reconstruction surgery or is considering genitourinary reconstruction surgery within the next 24 months.
• 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 suboptimally controlled Type I or Type II diabetes, as defined by an HbA1C ≥ 7.0%. NOTE: HbA1C results reported within the last 60 days prior to consent are acceptable.
• Have documented renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min/1.73 m² or evidence of hydronephrosis on renal ultrasound or CT urogram. NOTE: Renal function panel and renal ultrasound or CT urograms performed within the last 365 days prior to consent are acceptable.
• Have any history of dialysis or kidney transplant.
• Have a history of kidney or bladder stones within the last 5 years.
• Have any history of bladder cancer.
• Have any history of pelvic cancer diagnosis (e.g. uterine, ovarian, rectal), unless disease-free for ≥ 2 years measured from the day of consent.
• Have any history of radiation cystitis.

Sponsors & Collaborators

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

Study Sites (2)

Sydney Adventist Hospital

Wahroonga, New South Wales, 2076, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, 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: February 9, 2026

Record last verified: 2026-02

Locations

AU (2)