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Spinal Cord Injury Center, Research

Sacral neuromodulation for neurogenic lower urinary tract dysfunction: A randomized, placebo- controlled, double blind clinical trial

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Background: Sacral neuromodulation (SNM) has become a well-established and widely accepted treatment for refractory non-neurogenic lower urinary tract dysfunction (LUTD), but its value in patients with neurological disorders is unclear. In a recent systematic review and meta- analysis, we found evidence indicating that SNM might be effective and safe for the treatment of patients with neurogenic LUTD. However, the number of investigated patients is low and there is a lack of randomized controlled trials.

the primary objective of this study is to investigate the efficacy of SNM for neurogenic LUTD for improving key bladder diary variables as compared to placebo stimulation. Secondary objectives are to assess the safety of SNM for neurogenic LUTD, the urodynamic parameters, and costs.

Importance and impact of the study:
The effectiveness of standard treatment of neurogenic LUTD is often unsatisfactory. Thus, it is of utmost importance to know whether SNM, which is minimally invasive and completely reversible, is a valuable treatment option for patients with neurogenic LUTD. To our knowledge, the present study will be the first adequately powered, randomized controlled trial assessing SNM for neurogenic LUTD. This trial will give significant insights into the difficult management of refractory neurogenic LUTD. If SNM turns out to be effective in the neurological population it would have major implications for daily practice and would completely revolutionize the management of neurogenic LUTD. In addition, this multidisciplinary trial will significantly influence all involved disciplines, i.e. neuro-urology, urology, and neurology and it will promote future multidisciplinary, multicentre approaches, and collaborations further improving patients’ medical care.