- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957137
InterStim® Sacral Nerve Modulation Cycling Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This feasibility study will assess the following outcomes:
- Voiding diaries
- Patient reported assessments of response or satisfaction
- Adverse events
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Saint Petersburg, Florida, United States, 33710
- Pinellas Urology, Inc.
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Healthcare
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Minnesota
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Woodbury, Minnesota, United States, 55125
- Metro Urology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months
- Implanted with tined lead models 3889 or 3093
- Tined lead is located at S3 as determined by sensory or motor responses or x-ray or fluoroscopy
- Currently showing some efficacy with an InterStim device but has the potential to be optimized per the opinion of the Investigator
- Primary diagnosis before InterStim implant is urinary urge incontinence.
- Must be willing to maintain her current regimen (dosage and frequency) of any overactive bladder (OAB) medication (anticholinergic, antimuscarinic or Myrbetriq (Mirabegron)) or tricyclic antidepression medication over the study duration, if applicable.
- Female subject 18 years of age or older
- Willing and able to accurately complete voiding diaries and questionnaires, attend visits (within the visit windows +7 days), and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study
- Have had no more than one (InterStim) reprogramming at or within 28 days at or prior to randomization
Able to consent to participate by signing the Informed Consent Form
Exclusion Criteria:
- History of Multiple sclerosis
- History of Reiter's syndrome
- History of spinal cord injury or a cerebral vascular accident (CVA)
- History of diabetes unless the diabetes is well-controlled through diet and/or medications
- Active symptomatic urinary tract infection (UTI)
- Stress incontinence as the primary diagnosis
- Urgency frequency as a primary diagnosis
- Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary diagnosis
- Interstitial cystitis as the primary diagnosis
- Urinary retention as the primary diagnosis
- Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study
- Bilateral lead placement
- Have other implantable neurostimulator, pacemaker, or defibrillator
- Have knowledge of planned diathermy, microwave exposure, high output ultrasonic exposure, RF energy exposure, or MRI scans not included within the scanning conditions provided within the MRI Guidelines for InterStim Therapy neurostimulation systems.
- Have an anticipated system modification within the next 5 months
- Women who are pregnant or planning to become pregnant (women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to randomization visit)
- Subjects who frequently use the patient programmer to change device program settings ("frequently" is defined as at least once a day and does not include shutting off the device for safety purposes)
- Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol.
- Study site personnel will contact the Medtronic Study Manager (or designee) to determine if a potential subject who plans to enroll in an investigational device or drug trial, or is currently enrolled in an investigational device or drug trial is eligible for this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Continuous
The device parameter will be continuous.
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|
Other: Cycling Parameter #1
The device parameter will be cyclic program #1.
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Other: Cycling Parameter #2
The device parameter will be cyclic program #2.
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Other: Cycling Parameter #3
The device parameter will be cyclic program #3.
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Other: No Stimulation
Following the randomized portion of the study, an assessment was conducted to estimate the effect of a month of no stimulation on incontinence.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion
Time Frame: 4 weeks
|
Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting.
Only the last 7-day diaries were used for the analysis.
The first 3 weeks were used as an adjustment period.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of Urgency - Randomized Portion
Time Frame: 4 week
|
Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting.
The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis.
The first 3 weeks were used as an adjustment period.
|
4 week
|
Number of Pads Used Per Day - Randomized Portion
Time Frame: 4 weeks
|
Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting.
Only the last 7-day diaries were used for the analysis.
The first 3 weeks were used as an adjustment period.
|
4 weeks
|
Global Response Assessment (GRA) - Randomized Portion
Time Frame: 4 weeks
|
Summary statistics of GRA at different cycling settings are provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved). Percentages of subjects reported worse, same or better under each cycling setting since starting the study are presented. |
4 weeks
|
Number of UUI Episodes Per Day - no Stimulation
Time Frame: 4 Weeks
|
UUI episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation.
Only the last 7-day diaries were used for the analysis.
The first 3 weeks were used as an adjustment period.
|
4 Weeks
|
Degree of Urgency - no Stimulation
Time Frame: 4 weeks
|
Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation.
The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis.
The first 3 weeks were used as an adjustment period.
|
4 weeks
|
Number of Pads Used Per Day - no Stimulation
Time Frame: 4 Weeks
|
Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation.
Only the last 7-day diaries were used for the analysis.
The first 3 weeks were used as an adjustment period.
|
4 Weeks
|
Global Response Assessment - no Stimulation
Time Frame: 4 Weeks
|
Summary of GRA under no stimulation setting is provided.
The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study.
Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved.
The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).
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4 Weeks
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Adverse Events - no Stimulation
Time Frame: 4 Weeks
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Summary of adverse device effects when subjects were under no stimulation is provided.
Percentage of subjects experiencing any type of Adverse Device Effect under no stimulation is presented.
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4 Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven W Siegel, MD, Metro Urology
- Principal Investigator: Shaw Zhou, MD, Pinellas Urology, Inc.
- Principal Investigator: Karl Kreder, Jr., MD, MBA, University of Iowa Healthcare
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1670
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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