Noninvasive spinal neuromodulation mitigates symptoms of idiopathic overactive bladder

Abstract

Background: Overactive bladder (OAB) affects 12 to 30% of the world's population. The accompanying urinary urgency, frequency and incontinence can have a profound effect on quality of life, leading to depression, social isolation, avoidance of sexual activity and loss of productivity. Conservative measures such as lifestyle modification and pelvic floor physical therapy are the first line of treatment for overactive bladder. Patients who fail these may go on to take medications, undergo neuromodulation or receive injection of botulinum toxin into the bladder wall. While effective, medications have side effects and suffer from poor adherence. Neuromodulation and botulinum toxin injection are also effective but are invasive and not acceptable to some patients.

Methods: We have developed a novel transcutaneous spinal cord neuromodulator (SCONE™,) that delivers multifrequency electrical stimulation to the spinal cord without the need for insertion or implantation of stimulating electrodes. Previously, multifrequency transcutaneous stimulation has been demonstrated to penetrate to the spinal cord and lead to motor activation of detrusor and external urethral sphincter muscles. Here, we report on eight patients with idiopathic overactive bladder, who underwent 12 weeks of SCONE™ therapy.

Results: All patients reported statistically significant clinical improvement in multiple symptoms of overactive bladder, such as urinary urgency, frequency and urge incontinence. In addition, patients reported significant symptomatic improvements as captured by validated clinical surveys.

Conclusion: SCONE™ therapy represents the first of its kind therapy to treat symptoms of urgency, frequency and urge urinary incontinence in patients with OAB.

Trial registration: The study was listed on clinicaltrials.gov ( NCT03753750 ).

Keywords: Lower urinary tract; Non-invasive spinal cord stimulation; Overactive bladder; Urge urinary incontinence; Urodynamics.

Conflict of interest statement

V.R.E, holds shareholder interest in Onward and hold certain inventorship rights on intellectual property licensed by The Regents of the University of California to Onward.

V.R.E, E.K, and PG hold shareholder interest in SpineX Inc. and hold certain inventorship rights on intellectual property licensed by The Regents of the University of California to SpineX Inc.

© 2022. The Author(s).

Figures

Fig. 1

A Schematic representation of experimental setup. B Step by step representation of position the anode and cathode and C Electrical waveforms used in the current study

Fig. 2

Voiding diary characteristics. A Mean ± SE (n = 8) total voiding frequency, B Mean ± SE (n = 7) urge urinary incontinence episodes per day, C Mean ± SE (n = 7) size of each incontinence episodes per day (Incontinence episodes were classified on a scale of 0 to 3, where 0 = no leak or dry pad/diaper, 1 = Small leak, 2 = Moderate leak and 3 = Heavy leak), D Mean ± SE (n = 8) Average urgency prior to voiding, E Mean ± SE (n = 8) frequency of zero urge voids and F Mean ± SE (n = 8) voiding frequency with high urge (levels 2 or higher; urgency rating for each void self-classified by the patient on a scale of 0 to 4, as follows: 0 = No urge, 1 = Minimal urge (Can wait 10 min or more), 2 = Moderate urge (Can wait 1 to 5 min), 3 = Strong urge (Can wait less than 1 min) and 4 = About to leak)

Fig. 3

Survey scores. A Mean ± SE (n = 8) OAB-q survey, B Mean ± SE (n = 8) ICIQ-UI survey and C Mean ± SE (n = 8) ICIQ-B survey

Fig. 4

A representative Urodynamic study from a patient before and after 12 weeks of therapy. Note the while the overall bladder capacity remained the same, the changes in 1st desire and strong desire relative to beginning of voiding demonstrates the increased bladder and sphincter control

Fig. 5

Distribution of the Patient Global Improvement Index (PGI-I), ranging from 1 (very much better) to 7 (very much worse)