Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder

NCT03753750 | Withdrawn

• 1 other identifier: HS-18-00382
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Incontinence, Urge; Neurogenic Bladder

Outcome Measures

Primary Outcomes (2)

• Number of urination and incontinence episodes over 72 hours

  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.

  4-12 weeks

• Score on overactive bladder questionnaires

  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.

  4-12 weeks

Secondary Outcomes (1)

• Cystometric bladder capacity, number of detrusor overactivity episodes during urodynamic studies.

  4-12 weeks

Study Arms (2)

Actual stimulation

EXPERIMENTAL

Subjects enrolled in the

Device: Noninvasive spinal cord stimulation

Sham stimulation

SHAM COMPARATOR

Device: Noninvasive spinal cord stimulation

Interventions

Noninvasive spinal cord stimulation DEVICE

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.

Actual stimulation; Sham stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (5)

• 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.

  PMID: 17049716 BACKGROUND

• 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.

  PMID: 26205686 BACKGROUND

• 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.

  PMID: 30008661 BACKGROUND

• 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.

  PMID: 23832777 BACKGROUND

• 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.

  PMID: 35317851 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Evgeniy I Kreydin

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Model Details: Blinded sham-controlled trial

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 27, 2018
• Study Start: March 24, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

US (1)