In a nutshell
This study investigated the effectiveness and safety of sacral neuromodulation (SNM) with the InterStim system in the treatment of overactive bladder (OAB) in real-world practice. Researchers suggested that this treatment is associated with improved effectiveness and quality of life in these patients.
Some background
Overactive bladder (OAB) 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 a sudden, uncontrolled need to urinate.
The first-line therapy for OAB is a lifestyle change and medication when needed. However, a significant number of patients do not complete their treatment due to limited improved outcomes. SNM is a type of electrical stimulation therapy. SNM 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). SNM is recommended as third-line therapy for the treatment of overactive bladder. However, too little is known about the long-term safety and effectiveness of SNM with the InterStim system in current medical practice.
Methods & findings
In total, 301 patients with OAB 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 (from 12.7 to 8.6 per day) or a replacement (from 11.5 to 7.9 per day).
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.
The bottom line
This study concluded that SNM with the InterStim system is associated with improved effectiveness, toxicity, and quality of life in patients with OAB.
The fine print
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.
Published By :
European urology focus
Date :
Sep 06, 2020
