Clinical trial NCT03753750: Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder
Official title: Evaluation of Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overactive Bladder
Incontinence, Urge
Neurogenic Bladder
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2018-11-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded sham-controlled trial
Primary purpose: TREATMENT

Brief summary: Overactive bladder (OAB) affects 12-30% of the world's population. The accompanying urinary urgency, urinary frequency and incontinence can impair the ability to work, interact in social activities and can result in poor social functioning. Multiple treatment modalities are available for overactive bladder. However, each therapy has drawbacks that limit its application in certain patient populations. For example, oral medications have significant side effects and suffer from poor adherence. Botulinum toxin injection into the bladder wall is invasive, requires re-treatment on a regular basis and carries a risk of urinary retention. Current neuromodulatory techniques are invasive and require highly-specialized care. Therefore, a need exists for a non-invasive, well-tolerated and easily administered therapy for OAB. Transcutaneous spinal cord stimulation (TSCS) has been developed and tested in able bodied individuals to initiate locomotor function as well as in the SCI population for lower extremity and upper extremity function. More recently, we have tested this SCI patients to enable lower urinary tract function and decrease detrusor overactivity, resulting in improved continence.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 80 years
2. Known diagnosis of overactive bladder, confirmed by:

   * presence of urinary frequency, urgency
   * frequent small-volume voids on frequency-volume chart
   * high score on ICIQ-OAB, ICIQ-OABQOL, and OAB-q questionnaires

Exclusion Criteria:

1. Younger than 18 years of age
2. Older than 80 years of age
3. Presence of lower urinary tract symptoms suggestive of urinary retention or obstruction
4. Finding of an elevated post-void residual (\>100 ml) on an ultrasonographic bladder scan
5. History of spinal cord injury, spina bifida or other neurological disease affecting the spinal cord
6. Acute or current urinary tract infection
7. History of neuromodulation for overactive bladder (sacral nerve stimulation or peripheral tibial nerve stimulation)
8. Current or planned pregnancy

Primary outcomes:
measure: Number of urination and incontinence episodes over 72 hours
timeFrame: 4-12 weeks
measure: Score on overactive bladder questionnaires
timeFrame: 4-12 weeks
Secondary outcomes:
measure: Cystometric bladder capacity, number of detrusor overactivity episodes during urodynamic studies.
timeFrame: 4-12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Evgeniy I Kreydin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
citation: Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
citation: Gad PN, Kreydin E, Zhong H, Latack K, Edgerton VR. Non-invasive Neuromodulation of Spinal Cord Restores Lower Urinary Tract Function After Paralysis. Front Neurosci. 2018 Jun 29;12:432. doi: 10.3389/fnins.2018.00432. eCollection 2018.
citation: Yoshimura N, Miyazato M, Kitta T, Yoshikawa S. Central nervous targets for the treatment of bladder dysfunction. Neurourol Urodyn. 2014 Jan;33(1):59-66. doi: 10.1002/nau.22455. Epub 2013 Jul 5.
citation: Zhong H, Liu E, Kohli P, Perez L, Edgerton VR, Ginsberg D, Gad P, Kreydin E. Noninvasive spinal neuromodulation mitigates symptoms of idiopathic overactive bladder. Bioelectron Med. 2022 Mar 23;8(1):5. doi: 10.1186/s42234-022-00087-x.