Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Kreydin | "Urinary Bladder, Overactive"
Previous Study | Return to List | Next Study

Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03753750
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Evgeniy I. Kreydin, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Incontinence, Urge Neurogenic Bladder Device: Noninvasive spinal cord stimulation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded sham-controlled trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder
Estimated Study Start Date : March 24, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Actual stimulation
Subjects enrolled in the
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.

Sham Comparator: Sham stimulation 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753750


Contacts
Layout table for location contacts
Contact: Egeniy I Kreydin, M.D. 818-790-1278 uscbrainbladder@gmail.com

Locations
Layout table for location information
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Evgeniy I Kreydin, MD    818-790-1278 ext 2    uscbrainbladder@gmail.com   
Sponsors and Collaborators
University of Southern California
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Evgeniy I Kreydin University of Southern California
Publications:
Layout table for additonal information
Responsible Party: Evgeniy I. Kreydin, Assistant Professor of Urology, University of Southern California
ClinicalTrials.gov Identifier: NCT03753750    
Other Study ID Numbers: HS-18-00382
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder, Neurogenic
Urinary Incontinence, Urge
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Neurologic Manifestations
Nervous System Diseases
Urinary Incontinence
Urination Disorders