Unilateral versus bilateral sacral neuromodulation test in the treatment of refractory idiopathic overactive bladder: A randomized controlled pilot trial

Abstract

Aim: To compare treatment success rate in terms of improvement of bladder overactivity between unilateral and bilateral sacral neuromodulation testing. Methods: A multicentric, parallel, randomized, open pilot trial (October 2012-September 2017) was conducted. Participants presented primary overactive bladder resistant to first-line treatments. Patients were excluded in case of secondary bladder, pelvic, or neurological condition. Patients were randomized between bilateral testing (n = 28) or unilateral testing (n = 27), to determine the best functional response before final implantation. The primary outcome was the rate of patients presenting at least 50% of clinical improvement at 1 month on urinary frequency, number of urge incontinence episodes or number of urinary urgency episodes. Symptom severity, implantation success rate, uroflowmetry, device tolerance, complications, and quality of life were also assessed. Results: Fifty-five patients have been included. The rate of patients presenting at least one significant clinical improvement at month 1 was 62% in the bilateral group versus 84% in the unilateral group (P = .0891), RR = 0.74 (0.51; 1.07). There was no significant difference between bilateral and unilateral groups in terms of improvement of urinary frequency (0% and 17%; P = .1115), number of urge incontinence episodes (52% and 63%; P = .4929) or number of urinary urgency episodes (57% and 74%; P = .2411). More complications were reported in the bilateral group than in the unilateral group (9 [47%] vs 4 [16%], respectively; P = .0239). Conclusion: Systematic bilateral sacral neuromodulation testing before final implantation did not appear to increase success rate compared with unilateral stimulation in the treatment of overactive bladder.

Physical Agent-Based Treatments for Overactive Bladder: A Review

“…The intention-to-treat model found that the OAB therapeutic success rate at 6 months is 61% for P-SNS compared to 42% for PT ( p = 0.02) [ 18 ]. P-SNS significantly reduces the frequency and number of urgency episodes and the number of urinary incontinence episodes [ 19 ]. Moreover, this device appears to be effective for the long term, with sustained quality of life improvements and an acceptable safety profile through 3–5 years in OAB subjects [ 20 , 21 ].…”

Traitement du syndrome clinique d’hyperactivité vésicale non neurologique réfractaire

“…Une stimulation bilatérale a été proposée pour essayer d'améliorer les résultats lors de la période de test mais malheureusement l'étude contrôlée multicentrique française était négative [40].…”

Optogenetic Neuromodulation of the Urinary Bladder

“…In the last two decades, sacral neuromodulation has become an acceptable intervention for overactive bladder, nonobstructive urinary retention, neurogenic LUT dysfunction, and interstitial cystitis/bladder pain syndrome, especially in patients who do not respond to pharmaceutical management (2,3). However, even electrical stimulation of sacral nerve is mature and has been applied in clinic for decades, it still fails in many patients (4,5). The underlying mechanisms are not thoroughly understood, and the nonspecific nature of electrical stimulation offers part of the reasons.…”

“…The underlying mechanisms are not thoroughly understood, and the nonspecific nature of electrical stimulation offers part of the reasons. Similarly, the off-target effects caused by the indiscriminate activation of all types of cells throughout a volume of tissue, including pain, abnormal electrical shock sensation, changes in intestinal function, and so on, limit its applications to a certain extent (4).…”