Akyva implant for underactive bladder first human trial
Part of Kidney & urinary, Women’s health & pregnancy clinical trials.
This trial tests a new implant called Akyva for people with underactive bladder (not enough bladder muscle contraction). It may help you empty your bladder better without needing catheters as often.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are at least 22 years old (or 22–70 if you have a spinal cord injury)
- You can start at least 3 urinations on your own over a week
- You use catheters to empty your bladder at least 7 times a week
- You are healthy enough for surgery under general anesthesia
- No active infections, bleeding disorders, or other conditions that could make surgery risky
- You do not have medical implants like a pacemaker (unless it's an inactive sacral neuromodulation device)
- You have no history of bladder cancer or radiation cystitis
- Your kidney function is good (eGFR above 50)
- You do not have severe bladder outlet blockage or diabetes with poor control (HbA1C less than 7.0%)
- You are not pregnant and use birth control if you could become pregnant
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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