Urge IncontinenceNCT00928499
Trial of Continuous Versus Cyclic Stimulation in Interstim Therapy
A study testing Interstim (SNS) in people with Urge Incontinence, run by University of California, Irvine at 1 site in United States.
Trial summary
Sacral Nerve Stimulation (SNS) delivers non-painful, mild electrical pulses to the sacral nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal voiding function. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urge Incontinence
- What is being tested?
- Interstim (SNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are eligible to participate in this study if you have the diagnosis of urge/frequency or urge incontinence and have undergone a successful Interstim trial and are planning on proceeding with IPG placement.
- All subjects must have had a minimum of a 50% improvement of one or more of the parameters being measured on the voiding diary to be considered a candidate for implant.
- Eligibility criteria also include non-pregnant women over the age of 18 who are able to provide informed consent and are willing to accept randomization.
Who cannot join
- You are not eligible to participate in this study if:
- you are under 18 years of age;
- pregnant or planning to become pregnant;
- have underlying neurological disease;
- stress incontinence;
- unable to read English;
- inability to complete the voiding diary; and
- inability to complete the follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
Sacral Nerve Stimulation (SNS) delivers non-painful, mild electrical pulses to the sacral nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal voiding function. Sacral nerve stimulation is indicated for refractory voiding dysfunction including urinary urgency/frequency, urinary urge incontinence, and nonobstructive urinary retention. Since its introduction, SNS has undergone significant improvements in design and application so that implantation is now a minimally invasive procedure under local and intravenous (IV) sedation. However, despite the progress made in advancing this therapy to a minimally invasive procedure, there are neither data nor guidelines on ideal program settings. The purpose of this study is to evaluate the programming parameter of cyclic versus continuous stimulation on efficacy of the therapy. If the therapy is equally efficacious at both settings, the cyclic setting has the advantage of resulting in a longer battery life.
Read the detailed description
The components of SNS include a quadripolar lead wire that is placed adjacent to a sacral nerve root (typically S3), and an implantable pulse generator (IPG) that the lead wire is attached to. The IPG provides the electrical impulse and has several parameters that are amenable to adjustment including rate, strength and length of stimulation. Additionally, the stimulation can be programmed to be continuous or cyclic. If the therapy is equally efficacious at both settings, the cyclic setting has the advantage of resulting in a longer battery life. This would prolong the time interval between IPG replacements which would reduce the number of times a patient is exposed to a surgical procedure and may have a substantial impact on reducing cost to the healthcare system.
Participants will be randomized into one of two groups: either cyclic stimulation or continuous stimulation after IPG placement and will continue with this setting for four weeks. Subjects will return to the office 4 weeks post-op. They will complete a 3-day consecutive voiding diary just prior to their study visit. The subject will then undergo reprogramming to change the stimulation to the alternate pattern (from cyclic to continuous or vice versa as appropriate) keeping all other parameters the same. Subjects will be asked to return to the office 4 weeks after being switched to the alternate setting. She will complete a 3-day consecutive voiding diary just prior to the visit. The subject will also be asked their preference of mode of stimulation and the reason for their choice. After this visit, the participant will be switched to the mode of stimulation that is most efficacious for her.
- Conditions
- Urge Incontinence
- Being tested
- Interstim (SNS)
- Keywords
- urge/frequency, urge incontinence, Interstim, after success Interstim planning IPG placement
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstim (SNS)Device
Also called Sacral nerve stimulation
Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
| Study group | Role | What they receive |
|---|---|---|
| Interstim - continuous | Other | Continuous stimulation Receives: Device: Interstim (SNS) |
| Interstim - cyclic | Other | Cyclic stimulation Receives: Device: Interstim (SNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Micturitions in 24 Hours
Collected in the 3 day voiding diary depending on their primary diagnosis
Measured: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Number of Urge Incontinence Episodes in 24 Hours
Collected in the 3 day voiding diary depending on their primary diagnosis
Measured: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urge IncontinenceStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Noblett, University of California, Irvine
- Investigators
- Karen Noblett, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928499
- Sponsor's protocol ID
- 2009-6736
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2009
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy
- ClinicalTrials.gov ID
- NCT00928499
- Acronym / sponsor ID
- 2009-6736
- Conditions
- Urge Incontinence
- Keywords
- urge/frequency, urge incontinence, Interstim, after success Interstim planning IPG placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 6 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sacral Nerve Stimulation (SNS) delivers non-painful, mild electrical pulses to the sacral nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal voiding function. Sacral nerve stimulation is indicated for refractory voiding dysfunction including urinary urgency/frequency, urinary urge incontinence, and nonobstructive urinary retention. Since its introduction, SNS has undergone significant improvements in design and application so that implantation is now a minimally invasive procedure under local and intravenous (IV) sedation. However, despite the progress made in advancing this therapy to a minimally invasive procedure, there are neither data nor guidelines on ideal program settings. The purpose of this study is to evaluate the programming parameter of cyclic versus continuous stimulation on efficacy of the therapy. If the therapy is equally efficacious at both settings, the cyclic setting has the advantage of resulting in a longer battery life.
Detailed description
The components of SNS include a quadripolar lead wire that is placed adjacent to a sacral nerve root (typically S3), and an implantable pulse generator (IPG) that the lead wire is attached to. The IPG provides the electrical impulse and has several parameters that are amenable to adjustment including rate, strength and length of stimulation. Additionally, the stimulation can be programmed to be continuous or cyclic. If the therapy is equally efficacious at both settings, the cyclic setting has the advantage of resulting in a longer battery life. This would prolong the time interval between IPG replacements which would reduce the number of times a patient is exposed to a surgical procedure and may have a substantial impact on reducing cost to the healthcare system.
Participants will be randomized into one of two groups: either cyclic stimulation or continuous stimulation after IPG placement and will continue with this setting for four weeks. Subjects will return to the office 4 weeks post-op. They will complete a 3-day consecutive voiding diary just prior to their study visit. The subject will then undergo reprogramming to change the stimulation to the alternate pattern (from cyclic to continuous or vice versa as appropriate) keeping all other parameters the same. Subjects will be asked to return to the office 4 weeks after being switched to the alternate setting. She will complete a 3-day consecutive voiding diary just prior to the visit. The subject will also be asked their preference of mode of stimulation and the reason for their choice. After this visit, the participant will be switched to the mode of stimulation that is most efficacious for her.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interstim - continuous | Other | Device: Interstim (SNS)Continuous stimulation |
| Interstim - cyclic | Other | Device: Interstim (SNS)Cyclic stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- You are eligible to participate in this study if you have the diagnosis of urge/frequency or urge incontinence and have undergone a successful Interstim trial and are planning on proceeding with IPG placement.
- All subjects must have had a minimum of a 50% improvement of one or more of the parameters being measured on the voiding diary to be considered a candidate for implant.
- Eligibility criteria also include non-pregnant women over the age of 18 who are able to provide informed consent and are willing to accept randomization.
Key exclusion criteria (8 listed)
- You are not eligible to participate in this study if:
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 |
|---|---|---|
| Interstim (SNS)Also: Sacral nerve stimulationRandomized Controlled Trial of Continuous vs. Cyclic Stimulation in Interstim Therapy | Device | Interstim - continuous, Interstim - cyclic |
Primary outcome
Number of Micturitions in 24 Hours
Time frame: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Collected in the 3 day voiding diary depending on their primary diagnosis
Number of Urge Incontinence Episodes in 24 Hours
Time frame: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed
Collected in the 3 day voiding diary depending on their primary diagnosis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Urge Incontinence
RecruitingPhase 2
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INTIBIA Pivotal Study
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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.
Karen Noblett, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interstim (SNS) in people with Urge Incontinence, run by University of California, Irvine 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 3 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: finished, as of the sponsor's last update on 6 Oct 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Micturitions in 24 Hours (time frame: After 4 weeks of stimulation a 3-day consecutive voiding diary was completed). 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?
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 6 Oct 2021.