Patient Referral Opportunity - Study for Underactive Bladder
Researchers are currently undertaking a first-in-human, multicenter clinical 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.
Australian sites have now started enrollment in this AKYVA-FIH study.
The study seeks to determine if iota’s Direct Bladder Wall Stimulation system is safe to use and if it has any possible side effects. Researchers will see if the device can help patients urinate without the need for catheterization; and if there is any improvement in the amount of leftover urine in the bladder after urinating or trying to urinate. Read more about the study on the FDA website.
The Akyva device is designed to deliver stimulation directly to the anterior bladder wall to initiate detrusor contraction and support bladder emptying in patients with non-neurogenic urinary retention. Key eligibility criteria include:
- Adults ≥ 22 years of age
- Non-neurogenic, non-obstructive urinary retention symptoms
- Currently using clean intermittent catheterization (CIC) at least once daily, but not fully catheter dependent
- Medically suitable for abdominal-pelvic surgery under general anesthesia and able to attend follow-up visits
As a first-in-human study, the primary objective is safety evaluation. Additional assessments include surgical feasibility, changes in catheterization frequency, post-void residual volume, and voiding efficiency.
If you have patients who may be appropriate candidates and would like to discuss referral, please email the Akyva Study team. Please do not include patient-identifying information in your initial correspondence.