Overactive BladderNCT03753750
Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder
A study testing Noninvasive spinal cord stimulation in people with Overactive Bladder and Incontinence, Urge, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overactive Bladder, Incontinence, Urge, Neurogenic Bladder
- What is being tested?
- Noninvasive spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Evaluation of Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder
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
- Being tested
- Noninvasive spinal cord stimulation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive spinal cord stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Actual stimulation | Experimental | Subjects enrolled in the Receives: Device: Noninvasive spinal cord stimulation |
| Sham stimulation | Sham comparator | Not described Receives: Device: Noninvasive spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4-12 weeks
Secondary outcomes (1)
Cystometric bladder capacity, number of detrusor overactivity episodes during urodynamic studies.
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.
Measured: 4-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start24 Mar 2020 (estimated)
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Insufficient enrollment due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Evgeniy I. Kreydin, University of Southern California
- Investigators
- Evgeniy I Kreydin, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753750
- Sponsor's protocol ID
- HS-18-00382
- Status last verified
- May 2022
- First submitted
- 19 Nov 2018
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 17049716Gerasimenko 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.
PubMed 26205686Gad 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.
PubMed 30008661Yoshimura 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.
PubMed 23832777Zhong 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.
PubMed 35317851
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Noninvasive Spinal Cord Stimulation for Neurogenic and Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT03753750
- Acronym / sponsor ID
- HS-18-00382
- Conditions
- Overactive Bladder, Incontinence, Urge, Neurogenic Bladder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient enrollment due to COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 24 Mar 2020 (estimated)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Blinded sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Actual stimulation | Experimental | Device: Noninvasive spinal cord stimulationSubjects enrolled in the |
| Sham stimulation | Sham comparator | Device: Noninvasive spinal cord stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years
- Known diagnosis of overactive bladder, confirmed by:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive spinal cord stimulationNoninvasive 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. | Device | Actual stimulation, Sham stimulation |
Primary outcome
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.
1 secondary outcome
Cystometric bladder capacity, number of detrusor overactivity episodes during urodynamic studies.
Time frame: 4-12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 17049716Irwin 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.
- Background: PubMed 26205686Gerasimenko 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.
- Background: PubMed 30008661Gad 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.
- Background: PubMed 23832777Yoshimura 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.
- Derived from this study: PubMed 35317851Zhong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeniy I Kreydin principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive spinal cord stimulation in people with Overactive Bladder and Incontinence, Urge, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of urination and incontinence episodes over 72 hours (time frame: 4-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753750, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.