Urinary Bladder, OveractiveEarly Phase 1NCT02992509
IVES for Treatment of UUI and OAB
A Early Phase 1 study testing EMED detruset(TM) intravesical electrical stimulation in people with Urinary Bladder, Overactive and Urinary Incontinence, Urge, run by Loma Linda University at 1 site in United States.
Trial summary
The pilot study is intended to show the efficacy of intravesical electrical stimulation in treating overactive bladder with or without frequency and/or urgency urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
- What is being tested?
- EMED detruset(TM) intravesical electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Nov 2015
- Phase
- Early Phase 1
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 18-90 years old
- Urinary urge incontinence OR overactive bladder
- Prior trial of medical treatment for UUI or OAB
Who cannot join
- pelvic organ prolapse greater than stage 1
- multiple sclerosis
- parkinson's disease
- spinal cord injury
- long-term DM type I
- prior surgeries that may affect innervation of the detrusor nerves or the spinal cord
Show all 12Show fewer
- pregnancy
- pacemaker/defibrillator
- PVR >150ml
- dementia
- Stress urinary incontinence
- intravesical botox injection within 1 year, PTNS within 6 months, or medical treatment for OAB within 3 weeks; bulking agent injection within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92354
About this study
Official title: EMED Detruset Intravesical Electrical Stimulation Catheter for Treatment of Urge Urinary Incontinence and Overactive Bladder Syndrome in Females
The pilot study is intended to show the efficacy of intravesical electrical stimulation in treating overactive bladder with or without frequency and/or urgency urinary incontinence.
Read the detailed description
The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or cannot tolerate other conservative treatments. EMED is interested in conducting a prospective randomized multi-center study of IVES therapy vs conventional UI treatments. In order to gain sufficient knowledge of the treatment effect and variability of IVES therapy to power an RCT, a pilot study will be initially conducted.
The pilot study is intended to show the efficacy of IVES in treating overactive bladder with or without frequency and/or urgency urinary incontinence with safety profile of IVES being no worse than with standard urological catheters.
A primary endpoint at 3 months showing reduction in incontinence events via a 7-level patient global impression of improvement will be established. Secondary endpoints will include PCI for subsets of symptoms, 3 day voiding diary, and patient satisfaction questionnaires.
Follow up at end of therapy and 3 months from the first therapy session will be conducted. 6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES therapy if it is found to be effective at 3 months after the first treatment
- Being tested
- EMED detruset(TM) intravesical electrical stimulation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMED detruset(TM) intravesical electrical stimulationDevice
There will be a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks. The electrical parameters utilized will be those previously determined to be appropriate for OAB and UUI. As the beneficial effect of electrical stimulation is dependent on a "maximal" level of stimulation, the stimulation voltage will be increased during the first minute of treatment until the maximum tolerated by the patient is established and then backed-off by 1-2 Volts. The therapy will continue for 15 minutes in total for each session. The VAS will be marked by the patient before each treatment session throughout the therapy period, and other questionnaires will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | This pilot study group is a prospective observational study. It is not blinded and there is no control. This is a single arm study (treatment group) which will receive intravesical electrical stimulation with a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks. Receives: Device: EMED detruset(TM) intravesical electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in incontinence
Primary endpoint is a reduction in incontinence events at 3 months post treatment as determined by a 7 point patient global impression of improvement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2014
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Siddighi, MD, Loma Linda University
- Investigators
- Sam Siddighi, MD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992509
- Sponsor's protocol ID
- 5130321
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No IPD will be shared
Publications
Hagerty JA, Richards I, Kaplan WE. Intravesical electrotherapy for neurogenic bladder dysfunction: a 22-year experience. J Urol. 2007 Oct;178(4 Pt 2):1680-3; discussion 1683. doi: 10.1016/j.juro.2007.03.188. Epub 2007 Aug 17.
PubMed 17707024Cheng EY, Richards I, Balcom A, Steinhardt G, Diamond M, Rich M, Donovan JM, Carr MC, Reinberg Y, Hurt G, Chandra M, Bauer SB, Kaplan WE. Bladder stimulation therapy improves bladder compliance: results from a multi-institutional trial. J Urol. 1996 Aug;156(2 Pt 2):761-4.
PubMed 8683778Hong CH, Lee HY, Jin MH, Noh JY, Lee BH, Han SW. The effect of intravesical electrical stimulation on bladder function and synaptic neurotransmission in the rat spinal cord after spinal cord injury. BJU Int. 2009 Apr;103(8):1136-41. doi: 10.1111/j.1464-410X.2008.08189.x. Epub 2008 Nov 18.
PubMed 19021629Lombardi G, Musco S, Celso M, Ierardi A, Nelli F, Del Corso F, Del Popolo G. Intravesical electrostimulation versus sacral neuromodulation for incomplete spinal cord patients suffering from neurogenic non-obstructive urinary retention. Spinal Cord. 2013 Jul;51(7):571-8. doi: 10.1038/sc.2013.37. Epub 2013 Apr 30.
PubMed 23628893
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMED Detruset Intravesical Electrical Stimulation Catheter for Treatment of Urge Urinary Incontinence and Overactive Bladder Syndrome in Females
- ClinicalTrials.gov ID
- NCT02992509
- Acronym / sponsor ID
- 5130321
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- First posted
- 14 Dec 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 pilot study is intended to show the efficacy of intravesical electrical stimulation in treating overactive bladder with or without frequency and/or urgency urinary incontinence.
Detailed description
The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or cannot tolerate other conservative treatments. EMED is interested in conducting a prospective randomized multi-center study of IVES therapy vs conventional UI treatments. In order to gain sufficient knowledge of the treatment effect and variability of IVES therapy to power an RCT, a pilot study will be initially conducted.
The pilot study is intended to show the efficacy of IVES in treating overactive bladder with or without frequency and/or urgency urinary incontinence with safety profile of IVES being no worse than with standard urological catheters.
A primary endpoint at 3 months showing reduction in incontinence events via a 7-level patient global impression of improvement will be established. Secondary endpoints will include PCI for subsets of symptoms, 3 day voiding diary, and patient satisfaction questionnaires.
Follow up at end of therapy and 3 months from the first therapy session will be conducted. 6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES therapy if it is found to be effective at 3 months after the first treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: EMED detruset(TM) intravesical electrical stimulationThis pilot study group is a prospective observational study. It is not blinded and there is no control. This is a single arm study (treatment group) which will receive intravesical electrical stimulation with a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 18-90 years old
- Urinary urge incontinence OR overactive bladder
- Prior trial of medical treatment for UUI or OAB
Key exclusion criteria (12 listed)
- pelvic organ prolapse greater than stage 1
- multiple sclerosis
- parkinson's disease
- spinal cord injury
- long-term DM type I
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 |
|---|---|---|
| EMED detruset(TM) intravesical electrical stimulationThere will be a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks. The electrical parameters utilized will be those previously determined to be appropriate for OAB and UUI. As the beneficial effect of electrical stimulation is dependent on a "maximal" level of stimulation, the stimulation voltage will be increased during the first minute of treatment until the maximum tolerated by the patient is established and then backed-off by 1-2 Volts. The therapy will continue for 15 minutes in total for each session. The VAS will be marked by the patient before each treatment session throughout the therapy period, and other questionnaires will be administered. | Device | Treatment |
Primary outcome
Reduction in incontinence
Time frame: 3 months
Primary endpoint is a reduction in incontinence events at 3 months post treatment as determined by a 7 point patient global impression of improvement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Background: PubMed 17707024Hagerty JA, Richards I, Kaplan WE. Intravesical electrotherapy for neurogenic bladder dysfunction: a 22-year experience. J Urol. 2007 Oct;178(4 Pt 2):1680-3; discussion 1683. doi: 10.1016/j.juro.2007.03.188. Epub 2007 Aug 17.
- Background: PubMed 8683778Cheng EY, Richards I, Balcom A, Steinhardt G, Diamond M, Rich M, Donovan JM, Carr MC, Reinberg Y, Hurt G, Chandra M, Bauer SB, Kaplan WE. Bladder stimulation therapy improves bladder compliance: results from a multi-institutional trial. J Urol. 1996 Aug;156(2 Pt 2):761-4.
- Background: PubMed 19021629Hong CH, Lee HY, Jin MH, Noh JY, Lee BH, Han SW. The effect of intravesical electrical stimulation on bladder function and synaptic neurotransmission in the rat spinal cord after spinal cord injury. BJU Int. 2009 Apr;103(8):1136-41. doi: 10.1111/j.1464-410X.2008.08189.x. Epub 2008 Nov 18.
- Background: PubMed 23628893Lombardi G, Musco S, Celso M, Ierardi A, Nelli F, Del Corso F, Del Popolo G. Intravesical electrostimulation versus sacral neuromodulation for incomplete spinal cord patients suffering from neurogenic non-obstructive urinary retention. Spinal Cord. 2013 Jul;51(7):571-8. doi: 10.1038/sc.2013.37. Epub 2013 Apr 30.
- Individual participant dataSharing planned: No. No IPD will be shared
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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.
Sam Siddighi, MD principal investigator
Loma Linda University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EMED detruset(TM) intravesical electrical stimulation in people with Urinary Bladder, Overactive and Urinary Incontinence, Urge, run by Loma Linda University 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 4 Jan 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in incontinence (time frame: 3 months). 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 NCT02992509, which also lists 4 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 4 Jan 2017.