Evaluating sacral neuromodulation with the InterStim system in patients with lower urinary symptoms

This study investigated the effectiveness and safety of sacral neuromodulation (SNM) with the InterStim system in the treatment of lower urinary symptoms such as urinary incontinence (UI) in real-world medical practice. Researchers suggested that this treatment is associated with improved effectiveness and quality of life in these patients.

Urinary symptoms such as UI is a common condition that negatively affects the quality of life of patients. Oftentimes, patients do not seek medical care and remain untreated due to embarrassment. This condition consists of involuntary leakage of urine.

SNM is a type of electrical stimulation therapy. It consists of the application of a medical device (InterStim) under the skin. This device sends impulses to the sacral nerve (responsible for the movements of the bladder). The long-term safety and effectiveness of SNM with the InterStim system in current medical practice for treating urinary symptoms such as UI remain under investigation.

In total, 301 patients were enrolled. Of these, 247 received a new permanent InterStim system (78%) or a replacement for an older one (22%). 204 patients completed the second follow-up after an average of 10 months. The main outcomes measured were changes in voids and urine leaks. Other outcomes measured were quality of life and disease severity. 

Urinary frequency (the number of voids per day) was reduced after 10 months in patients with urine leaks. This was observed in both patients who received a new device or a replacement.

The treatment response rate for patients with UI was 78% at 3 months and 84% at 10 months for patients who received a new device. The response rate was 71% at 3 months and 88% at 10 months for those who received a replacement implant. 

Complete continence (no mo involuntary urinary leakage) was seen in 46% of patients with a new implant and 53% of those with a replacement implant at 10 months. Disease severity and urinary symptoms were also significantly improved. 

Overall, 33% of patients reported side effects during an average time of 24.3 months. The most common side effects were pain or infections at the place of the implant. 20% of patients had implant revisions after application. This included 9% who had a permanent removal of the device.

This study concluded that SNM with the InterStim system is associated with improved effectiveness, toxicity, and quality of life in patients with urinary symptoms such as UI. 

This study included very diverse participants that received therapy with no defined protocol. The same SNM therapy was delivered with small variations among different patients. Therefore, results might differ in other settings or even countries.