Data weigh neuromodulation’s impact on QoL at 3 years

May 9, 2016

Evaluation of the InterStim system in patients with urgency incontinence, urgency frequency, or both suggests benefits beyond urinary symptom relief.

A new industry-funded study finds that sacral neuromodulation patients with urgency incontinence, urgency frequency, or both-almost all of whom were women-reported improvement in quality of life measures after 3 years of treatment. 

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The patients had failed an average of two medications, said lead author Karen Noblett, MD, of the University of California Riverside School of Medicine, Riverside. According to Dr. Noblett, the findings “suggest we probably should move to third-line therapies more quickly and not prescribe medication after medication if they’ve failed a couple.”

The InterStim system (Medtronic, Minneapolis) is FDA-approved for urinary incontinence, urgency-frequency, urinary retention, and fecal incontinence.

“It’s a third-line therapy after behavioral therapy and medications,” Dr. Noblett told Urology Times, and unique because patients can test the therapy over a trial period to see if it helps them. If the treatment works, then the device is implanted permanently in the body.

“It’s a very minimally invasive outpatient procedure, done with just local anesthesia and IV sedation,” she said.

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The new study, presented at the AUA annual meeting in San Diego, is a retrospective sub-analysis of a 5-year prospective study into the use of tined leads to hold the device in tissue. This research satisfies the FDA’s request for post-approval analysis, she noted.

Next: How patients fared

 

“We saw significant improvement,” Dr. Noblett said, “and we wanted to see if that would differ in patients with just urgency frequency versus those with urgency incontinence.”

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The study examined 272 subjects, 91% of whom were female, with an average age of 57 years. Of the subjects, 104 (51%) had both incontinence and frequency symptoms, while 54 (27%) had incontinence only, and 44 (22%) had frequency symptoms only.

All groups showed significant improvement over baseline at 36 months in Health Related Quality of Life and ICIQ-OABqol subscales of Concern, Coping, Sleep, Social, and Interference (all p<.0001).

“Not only are their diaries showing that they have fewer bladder symptoms, but these improvements are having a significant effect on their quality of life,” Dr. Noblett said.

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However, incontinence-only patients showed less improvement than the other groups in the Sleep subscale (p<.02), and they scored lower on the Coping subscale than those with both conditions.

Next: Interference measure results

 

On the Interference measure, which refers to interference with daily activities, about 80% of the subjects in all three groups reported they improved or greatly improved. This is an intriguing finding because some observers might assume that patients with incontinence would experience the greatest benefit due to the effects of leaking urine, Dr. Noblett said.

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While patients often don’t have full relief from urinary symptoms, she said, patients are often still pleased.

“They’ve gone from wearing a diaper to a panty liner. If you’re an adult woman, and you don’t have a diaper anymore, that will have a significant impact on quality of life.”

Overall, she said, “We were very happy to see the response was so robust and well-maintained over the 48 months we’ve collected the data,” she said. “We’ll continue to compile outcome data at 48 months and at 60 months of the 5-year period. We want to identify the ideal candidates for this therapy and predict who may respond more than others.”

The study was funded by Medtronic, and Dr. Noblett serves on the advisory board for Medtronic and was a participant in the InSite trial of the InterStim system. Several of Dr. Noblett’s co-authors were consultants/advisers and/or investigators for or employees of Medtronic.

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