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Posted by on Jan 18, 2019 in Overactive bladder | 0 comments

In a nutshell

This study looks at the safety and effectiveness of a rechargeable neuromodulation device. It concluded that the device was still effective for overactive bladder (OAB) after 1 year. It also found that patients found the recharging process satisfactory. 

Some background

Overactive Bladder (OAB) is a sudden, frequent urge to urinate. It may result in urge incontinence (inability to hold on to urine). OAB urination is usually eight or more times a day and two or more times at night. OAB can have a negative impact on quality of life. Medications can be taken to calm the muscles and nerves which cause OAB. These medications however, can carry side effects.

Another treatment option for OAB is nerve stimulation. This works by using electricity to stimulate nerves. These nerves affect the muscles of the bladder. Sacral neuromodulation (SNM) involves the implantation of a device near the sacral nerve in the spine. SNM devices usually have to be replaced after a few years, requiring more surgery. This study aims to prolong the life of an SNM device to reduce the need for more surgery. 

Methods & findings

51 patients were implanted with the Axonics r-SNM device. Patients returned for visits at 1 month, 3 months, 6 months and 1 year after the implantation. Patients were assessed for a response to the device. A response was classified as a reduction of 50% or more in urine leaks, a reduction of 50% or more in the number of urinations and having less than 8 urinations per day. Responses were recorded in a bladder diary. Patients also completed questionnaires on incontinence symptoms, quality of life and patient satisfaction with the device. Any complications were also recorded. 

At 1 year after the implant, the device was still effective in 72% of patients. There was significant improvement in patient quality of life. Urine leaks decreased from 8.3 per day to 1.8 per day at 1 year after implantation. The number of urinations per day reduced from 14.3 to 8 at 1 year. 77% of patients were satisfied with the device. 98% of patients found the recharging process satisfactory. Discomfort from stimulation occurred in 20% of patients. This discomfort was resolved after reprogramming the devices. One patient had the device removed due to infection at the implant site after implantation. Two patients had the device removed due to it being ineffective. 

The bottom line

This study concludes that rechargeable SNM devices are safe and effective for treating OAB. It also concludes that patients are satisfied with the recharging process. 

The fine print

The authors note that the study was not randomised or did not have a comparator group. This may affect the study's results. 

What’s next?

If you are interested in learning more about rechargeable SNM devices, talk to your doctor. 

Published By :

Neurourology and urodynamics

Date :

Dec 28, 2018

Original Title :
A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study.
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