Urge IncontinenceNCT02922842
A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
A study testing Transcutaneous Electrical Nerve Stimulation in people with Urge Incontinence and Overactive Bladder, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urge Incontinence, Overactive Bladder
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 1 May 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer.
- Patients with urge predominant mixed incontinence.
- Patients will need to have answered at "Yes" to "leakage related to feeling urgency" on the UDI 6 questionnaire.
- Female
- Over 18 years of age.
- English speaking who are able to give informed consent to participate in the study.
- Patients who have four urinary incontinence episodes.
Who cannot join
- Stress incontinence desiring surgical management.
- Previous treatment of refractory urge incontinence such as PTNS, SNS, or Intradetrusor onabotulinumtoxin A injections.
- Neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair.
- Urethral diverticulum.
- Daily catheterization due to urinary retention.
- The use of anticholinergic medications for less than 6 weeks.
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- Patients who have pacemakers in place.
- Patients with limited mobility requiring a wheelchair.
- Elevated PVR > 200 cc
- Untreated urinary tract infection, defined as symptoms and a urine culture with greater than 100,000 cfu/ ml within the last 1 month prior to treatment.
- Uncorrected Stage 3 prolapse.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.
- Conditions
- Urge Incontinence, Overactive Bladder
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Keywords
- transcutaneous electrical nerve stimulation
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS device
| Study group | Role | What they receive |
|---|---|---|
| Tibial Nerve | Active comparator | Transcutaneous electrical stimulation will be placed on the posterior tibial nerve. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
| Parasacral | Active comparator | Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
| Shoulder | Sham comparator | Transcutaneous electrical stimulation will be placed on the shoulder. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incontinence episodes per day
Patients will self-report the number of incontinence episodes.
Measured: 6 weeks
Secondary outcomes (1)
Number of bladder voids per day
Patients will self-report the number of times they void their bladder.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startJul 2016
- Primary completion1 May 2018
- Study completion1 May 2018
Why it stopped: underenrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge IncontinenceStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922842
- Sponsor's protocol ID
- RSRB00060370
- Status last verified
- Nov 2018
- First submitted
- 25 May 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
- ClinicalTrials.gov ID
- NCT02922842
- Acronym / sponsor ID
- RSRB00060370
- Conditions
- Urge Incontinence, Overactive Bladder
- Keywords
- transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: underenrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tibial Nerve | Active comparator | Device: Transcutaneous Electrical Nerve StimulationTranscutaneous electrical stimulation will be placed on the posterior tibial nerve. |
| Parasacral | Active comparator | Device: Transcutaneous Electrical Nerve StimulationTranscutaneous electrical stimulation will be placed on the lower back near the s3 foramina. |
| Shoulder | Sham comparator | Device: Transcutaneous Electrical Nerve StimulationTranscutaneous electrical stimulation will be placed on the shoulder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer.
- Patients with urge predominant mixed incontinence.
- Patients will need to have answered at "Yes" to "leakage related to feeling urgency" on the UDI 6 questionnaire.
- Female
- Over 18 years of age.
Key exclusion criteria (11 listed)
- Stress incontinence desiring surgical management.
- Previous treatment of refractory urge incontinence such as PTNS, SNS, or Intradetrusor onabotulinumtoxin A injections.
- Neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair.
- Urethral diverticulum.
- Daily catheterization due to urinary retention.
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 |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENS device | Device | Parasacral, Shoulder, Tibial Nerve |
Primary outcome
Number of incontinence episodes per day
Time frame: 6 weeks
Patients will self-report the number of incontinence episodes.
1 secondary outcome
Number of bladder voids per day
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: underenrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Urge Incontinence and Overactive Bladder, run by University of Rochester 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Nov 2018. 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 stopped early (reason given: underenrollment). Results are not available in the source record.
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 incontinence episodes per day (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2018.