First-in-human study of a new device for underactive bladder
Part of Kidney & urinary, Women’s health & pregnancy clinical trials.
This study is testing an investigational device called Akyva to help people with underactive bladder who need to use catheters to empty their bladder. The device aims to improve bladder function and reduce the need for catheterization.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 22 years old or older (if you have a spinal cord injury, you must be between 22 and 70).
- You are able to pass urine on your own at least 3 times per week (based on a bladder diary).
- You currently use clean intermittent catheterization (inserting a thin tube to drain urine) at least 7 times per week.
- You are healthy enough to undergo surgery under general anesthesia.
- If you are a female who can become pregnant, you must agree to use birth control during the study.
- You have either no nerve cause for your bladder problem, or if you have a spinal cord injury, it must be at least 6 months old and affect the lower part of the spinal cord (L1 or below).
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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