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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06956209




Registration number
NCT06956209
Ethics application status
Date submitted
14/04/2025
Date registered
4/05/2025

Titles & IDs
Public title
Akyva First In Human
Scientific 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
Secondary ID [1] 0 0
iota-AS-AUS-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Underactive Bladder 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Direct Bladder Wall Stimulation

Experimental: Akyva System - 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


Treatment: Devices: Direct Bladder Wall Stimulation
The Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To characterize the safety of implantation and use of the Akyva System
Timepoint [1] 0 0
From enrollment to the end of the treatment at 180 days
Primary outcome [2] 0 0
To characterize the safety of implantation and use of the Akyva System
Timepoint [2] 0 0
From enrollment to the end of the treatment at 180 days
Secondary outcome [1] 0 0
To assess the effect of bladder wall stimulation on bladder emptying
Timepoint [1] 0 0
From enrollment to the end of the treatment at 180 days
Secondary outcome [2] 0 0
To assess the surgical feasibility of the Akyva system implantation procedure
Timepoint [2] 0 0
From enrollment to the end of the treatment at 180 days

Eligibility
Key inclusion criteria
* 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 from consent and has been diagnosed with underactive bladder (UAB).
* Is currently performing clean intermittent catheterization (CIC) for urinary retention at a rate of =3 catheterizations per day, as reflected in 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 prior to screening and has been performing CIC at least 180 days prior to screening. 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.
* Have Urodynamic measurements consistent with detrusor underactivity: (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.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* 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 = 6.0%.
* Have documented renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) = 60 mL/min/1.73 m² or evidence of hydronephrosis on renal ultrasound or CT urogram.
* Have any history of dialysis, kidney transplant, kidney or bladder stones, or 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.
* Have locally advanced malignancy or metastatic disease within the past five (5) years from the day of consent, with the exception of adequately treated or cured malignancy with no evidence of disease.
* Have had botulinum toxin injection in the bladder or pelvic floor in the past 12 months measured from the day of consent.
* Have any history of bladder-involved fistula or bladder diverticulum.
* Have any history of major bladder reconstructive surgeries.
* Have a bladder compliance < 20 mL/cmH2O measured during urodynamic study.
* Have a current underlying diagnosis of neurogenic bladder.
* Have any history of an overactive bladder or LUT symptoms suggestive of an overactive bladder.
* Have an iatrogenic cause of UAB symptoms in the opinion of the PI.
* Currently using an indwelling (e.g. Foley) catheter for bladder emptying, with an exception for nighttime-only use or treatment of post-surgical retention lasting < seven (7) days from time of surgery.
* Females who have had any prior abdominal sacrocolpopexy procedure for pelvic organ prolapse.
* Males with history of elevated PSA or prostate cancer undergoing further evaluation or treatment.
* 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 one year from the day of consent.
* Have any history of diagnosis of bladder outlet obstruction secondary to bladder neck stenosis, BPH or urethral stricture disease. Participants with prior surgical treatment of BPH with no clinical evidence of obstruction and do not require routine MRI may be included
* 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.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Iota Biosciences, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Astellas Pharma Inc
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
H&A LifeSciences Pty Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jami Maccombs
Address 0 0
Iota Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Akyva Study Team
Address 0 0
Country 0 0
Phone 0 0
510-954-6846
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06956209