Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder

• ClinicalTrials.gov Identifier: NCT03753750
• Recruitment Status: Withdrawn
• First Posted: November 27, 2018
• Last Update Posted: May 11, 2022
• Sponsor: University of Southern California
• Collaborator: University of California, Los Angeles
• Information provided by (Responsible Party): Evgeniy I. Kreydin, University of Southern California

Tracking Information

• First Submitted Date: November 19, 2018
• First Posted Date: November 27, 2018
• Last Update Posted Date: May 11, 2022
• Estimated Study Start Date: March 24, 2020
• Actual Primary Completion Date: January 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 22, 2018)

• Number of urination and incontinence episodes over 72 hours [ Time Frame: 4-12 weeks ]
  A voiding diary records the amount of fluid intake, the number of urinations and the number of incontinence episodes over 72 hours. The number of daily urinations and incontinence episodes will be compared at the beginning and the conclusion of the study. Changes in the number of daily urinations and incontinence episodes will be compared between participants in the stimulation and sham arms of the study.
• Score on overactive bladder questionnaires [ Time Frame: 4-12 weeks ]
  Each participant will complete two validated questionnaires pertaining to overactive bladder: OAB-q and ICIQ-OAB. The OAB-q generates a total score ranging between 33 points (best) to 198 points (worst). The ICIQ-OAB generates a total score ranging between 0 points (best) to 58 points (worst). The questionnaires will be completed at the initiation and completion of the study. Change in questionnaire scores between initiation and completion of the study will be assessed. Changes in questionnaire scores will be compared between participants in the stimulation and sham arms of the study.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 22, 2018)

Cystometric bladder capacity, number of detrusor overactivity episodes during urodynamic studies. [ Time Frame: 4-12 weeks ]

Urodynamic studies will be performed at the initiation and completion of the study. Urodynamic studies will be performed according to ICS (International Continence Society) criteria. Changes in cystometric capacity and number of detrusor overactivity episodes between initiation and completion of the study will be assessed. Changes in these parameters will be compared between participants in the stimulation and sham arms of the study.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder
• Official Title: Evaluation of Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Blinded sham-controlled trial

Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition

• Overactive Bladder
• Incontinence, Urge
• Neurogenic Bladder

Intervention

Device: Noninvasive spinal cord stimulation

Noninvasive spinal cord stimulation is a transcutaneous technique used to modulate the activity of the spinal cord. Subjects will undergo sham or actual stimulation 3-4 times a week for one hour at a time.

Study Arms

• Experimental: Actual stimulation
  Subjects enrolled in the
  Intervention: Device: Noninvasive spinal cord stimulation
• Sham Comparator: Sham stimulation
  Intervention: Device: Noninvasive spinal cord stimulation

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 5, 2022): 0
• Original Estimated Enrollment (submitted: November 22, 2018): 24
• Actual Study Completion Date: January 1, 2022
• Actual Primary Completion Date: January 1, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03753750
• Other Study ID Numbers: HS-18-00382
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Evgeniy I. Kreydin, University of Southern California
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Southern California
• Original Study Sponsor: Same as current
• Collaborators: University of California, Los Angeles

Investigators

• Principal Investigator: Evgeniy I Kreydin; University of Southern California

• PRS Account: University of Southern California
• Verification Date: May 2022