BridgeMD
New treatment option for Underactive Bladder
Official title Akyva First In Human
ClinicalTrials.gov ID: NCT06956209
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- List of Eligibility Criteria apply to both Non-neurogenic and Spinal Cord Injury (SCI) Neurogenic underactive bladder study participants unless...
- 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...
- Currently performing clean intermittent catheterization (CIC) for urinary retention at a rate of ≥7 catheterization episodes over the 7-day period...
- Are medically fit to withstand abdominal-pelvic surgery under general anesthesia, as evaluated by standard-of-care pre-operative surgical clearance.
You likely can't join if
- Have or are scheduled for implant of any active implantable medical device (e.g., pacemaker or intrathecal or infusion pump). Individuals with...
- 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...
- 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...
- 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...
See the full eligibility criteria
Who can join
- List of Eligibility Criteria apply to both Non-neurogenic and Spinal Cord Injury (SCI) Neurogenic underactive bladder study participants unless otherwise noted.
- 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...
- 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...
- 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).
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 a history of kidney or bladder stones within the last 5 years.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Woolloongabba, Queensland, Australia
- Melbourne N., Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Woolloongabba, Queensland, Australia; Melbourne N., Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.