Urinary Incontinence, Urgency-frequencyPhase 4InSite - OABNCT00547378
InSite for Over Active Bladder
A Phase 4 study testing InterStim and Standard Medical Therapy in people with Urinary Incontinence, Urgency-frequency and Overactive Bladder, run by MedtronicNeuro.
Trial summary
The purposes of this study are: 1. To provide evidence from a randomized controlled trial that InterStim Therapy provides better relief of symptoms of OAB than standard medical treatments in current use. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Urgency-frequency, Overactive Bladder
- What is being tested?
- InterStim and Standard Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Aug 2016
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of OAB including urinary urge incontinence or urgency-frequency
- Be male or female at least 18 years of age or older
- Be able to consent to participate by signing the Informed Consent
- Be willing and able to attend visits and comply with the study protocol including adequate operation of equipment
- Have failed or are not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification)
- Have failed or could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects) at least one anticholinergic or antimuscarinic medication AND have at least one anticholinergic or antimuscarinic medication not yet attempted
- Have been on current regiment of OAB medications or have not been on any OAB medications, for at least 4 weeks prior to beginning the baseline voiding diary
Who cannot join
- Have severe or uncontrolled diabetes or diabetes with peripheral nerve involvement
- Have concomitant medical conditions which would limit the success of the study procedure
- Have skin, orthopedic or neurologic anatomical limitations that could prevent successful placement of an electrode
- Have neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)
- Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
- Have urinary tract mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture
Show all 13Show fewer
- Have symptomatic urinary tract infection (UTI)
- Have implantable neurostimulators, pacemakers, or defibrillators
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
- Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
- Be a woman who is pregnant or planning to become pregnant or are a woman of child-bearing potential who is not using a medically-acceptable method of birth control
- Have a life expectancy of less than one year
- Have plans to enroll in another investigation device or drug trial during their participation in this trial, or currently enrolled in an investigational device or drug trial
About this study
Official title: Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)
The purposes of this study are:
- To provide evidence from a randomized controlled trial that InterStim Therapy provides better relief of symptoms of OAB than standard medical treatments in current use.
- To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.
Read the detailed description
Approximately 30 million Americans meet the criteria for overactive bladder (OAB). Urinary voiding dysfunction symptoms impose a significant physical and psychosocial impact on individuals, including loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. These symptoms can substantially affect a subject's daily activities.
Patients with OAB are managed with diet modification, bladder training or retraining, pelvic muscle rehabilitation, medication and biofeedback. Medications are used as the first-line therapy for urgency frequency and urinary urge incontinence.
InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments.
InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of the trail and Phase II the non-randomized portion.
Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects randomized to SMT.
Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297 enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of OAB.
- Being tested
- InterStim, Standard Medical Therapy
- Keywords
- overactive bladder, urinary incontinence, incontinence,Urgency-frequency
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStimDevice
Standard Medical TherapyDrug
Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | InterStim Therapy Receives: Device: InterStim |
| 2 | Active comparator | Standard Medical Therapy Receives: Drug: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomized Cohort: OAB Therapeutic Response
To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as:
- at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or
- at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (<8 voids/day) for subjects with urgency-frequency at baseline.
Measured: 6 months
All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery
To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33.
Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest.
Measured: 5 years
Secondary outcomes (2)
All Implanted Cohort: Tined Lead Migration Rate
To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. Suspected tined lead migration resulting in an adverse event of lead migration/dislodgement meets the definition of this endpoint.
Measured: 5 years
All Implanted Cohort: Infection Rate Associated With the Tined Lead
To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2016
- Study completionAug 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, Urgency-frequencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Siegel, MD, Study chair, Metro Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547378
- Sponsor's protocol ID
- Protocol 1634
- Acronym
- InSite - OAB
- Status last verified
- Nov 2017
- First submitted
- 18 Oct 2007
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Siegel S, Noblett K, Mangel J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Bennett J, Zylstra S, Berg KC, Kan F, Irwin CP. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015 Mar;34(3):224-30. doi: 10.1002/nau.22544. Epub 2014 Jan 10.
PubMed 24415559
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)
- ClinicalTrials.gov ID
- NCT00547378
- Acronym / sponsor ID
- InSite - OAB / Protocol 1634
- Keywords
- overactive bladder, urinary incontinence, incontinence,Urgency-frequency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Posted 12 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are:
- To provide evidence from a randomized controlled trial that InterStim Therapy provides better relief of symptoms of OAB than standard medical treatments in current use.
- To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.
Detailed description
Approximately 30 million Americans meet the criteria for overactive bladder (OAB). Urinary voiding dysfunction symptoms impose a significant physical and psychosocial impact on individuals, including loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. These symptoms can substantially affect a subject's daily activities.
Patients with OAB are managed with diet modification, bladder training or retraining, pelvic muscle rehabilitation, medication and biofeedback. Medications are used as the first-line therapy for urgency frequency and urinary urge incontinence.
InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments.
InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of the trail and Phase II the non-randomized portion.
Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects randomized to SMT.
Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297 enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: InterStimInterStim Therapy |
| 2 | Active comparator | Drug: Standard Medical TherapyStandard Medical Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a diagnosis of OAB including urinary urge incontinence or urgency-frequency
- Be male or female at least 18 years of age or older
- Be able to consent to participate by signing the Informed Consent
- Be willing and able to attend visits and comply with the study protocol including adequate operation of equipment
- Have failed or are not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification)
Key exclusion criteria (13 listed)
- Have severe or uncontrolled diabetes or diabetes with peripheral nerve involvement
- Have concomitant medical conditions which would limit the success of the study procedure
- Have skin, orthopedic or neurologic anatomical limitations that could prevent successful placement of an electrode
- Have neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)
- Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
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 | Device | 1 |
| Standard Medical TherapyOxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg | Drug | 2 |
Primary outcome
Randomized Cohort: OAB Therapeutic Response
Time frame: 6 months
To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as: * at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or * at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (<8 voids/day) for subjects with urgency-frequency at baseline.
All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery
Time frame: 5 years
To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33. Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest.
2 secondary outcomes
All Implanted Cohort: Tined Lead Migration Rate
Time frame: 5 years
All Implanted Cohort: Infection Rate Associated With the Tined Lead
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24415559Siegel S, Noblett K, Mangel J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Bennett J, Zylstra S, Berg KC, Kan F, Irwin CP. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015 Mar;34(3):224-30. doi: 10.1002/nau.22544. Epub 2014 Jan 10.
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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.
Steven Siegel, MD study chair
Metro Urology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing InterStim and Standard Medical Therapy in people with Urinary Incontinence, Urgency-frequency and Overactive Bladder, run by MedtronicNeuro.
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 13 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2017). 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?
Randomized Cohort: OAB Therapeutic Response (time frame: 6 months). 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 NCT00547378, which also lists 1 linked publication.
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 12 Dec 2017.