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The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.
This feasibility study will assess the following outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous | Other | The device parameter will be continuous. |
|
| Cycling Parameter #1 | Other | The device parameter will be cyclic program #1. |
|
| Cycling Parameter #2 | Other | The device parameter will be cyclic program #2. |
|
| Cycling Parameter #3 | Other | The device parameter will be cyclic program #3. |
|
| No Stimulation | Other | Following the randomized portion of the study, an assessment was conducted to estimate the effect of a month of no stimulation on incontinence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InterStim® (Device Programming) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Urgency - Randomized Portion | 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinellas Urology, Inc. | St. Petersburg | Florida | 33710 | United States | ||
| University of Iowa Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28914707 | Result | Siegel S, Kreder K, Takacs E, McNamara R, Kan F. Prospective Randomized Feasibility Study Assessing the Effect of Cyclic Sacral Neuromodulation on Urinary Urge Incontinence in Women. Female Pelvic Med Reconstr Surg. 2018 Jul/Aug;24(4):267-271. doi: 10.1097/SPV.0000000000000457. |
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Thirty subjects were enrolled into the study from Sept 10, 2013 through May 22, 2015 from 3 US centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Thirty subjects were randomized to 1 of 24 sequences with 4 cycling settings: 2 subjects discontinued early with 1 due to an AE, and 1 due to consent withdrawal. Twenty-eight subjects completed the randomization sequences . After that all subjects went through no stimulation for approximately 4 weeks, which was not part of randomization. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Portion |
|
| |||||||||||||||||||||||||||||||||
| No Stimulation |
|
Baseline descriptions provided were based on 24 subjects who first finished their randomized sequences who were included in the primary analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Who First Finished Unique Randomization Sequences | Baseline descriptions provided were based on 24 subjects who first finished unique randomization sequences, which are those subjects included in the primary analysis of the primary outcome. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | At time of consent |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | 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. | 24 subjects who first completed the unique randomization sequences were included in the analysis. | Posted | Mean | Standard Deviation | Number of UUI episodes/ Day | 4 weeks |
|
4 Weeks per period, a total of 4 periods in randomization portion. After randomized portion, each subject was under no stimulation for a period of 4 weeks, which was not part of the randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous | Subjects received continuous stimulation for approximately 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device stimulation issue | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment | Adverse device effects are presented in this table. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachael McNamara / Clinical Research Specialist | Pelvic Health and Gastric Therapies | 763.526.8107 | rachael.m.mcnamara@medtronic.com |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 4 week |
| Number of Pads Used Per Day - Randomized Portion | 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 | 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 | 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 | 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 | 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 | 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). | 4 Weeks |
| Adverse Events - no Stimulation | 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. | 4 Weeks |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Metro Urology | Woodbury | Minnesota | 55125 | United States |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Years implanted with InterStim therapy | Mean | Standard Deviation | years |
|
Subjects received cycling parameter #1 for approximately 4 weeks.
| OG002 | Cycling Parameter #2 | Subjects received cycling parameter #2 for approximately 4 weeks. |
| OG003 | Cycling Parameter #3 | Subjects received cycling parameter #3 for approximately 4 weeks. |
|
|
|
| Secondary | Degree of Urgency - Randomized Portion | 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. | 24 subjects who first completed unique randomization sequences were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 4 week |
|
|
|
|
| Secondary | Number of Pads Used Per Day - Randomized Portion | 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. | 24 subjects who first completed unique randomization sequences were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Pads per day | 4 weeks |
|
|
|
|
| Secondary | Global Response Assessment (GRA) - Randomized Portion | 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. | 24 subjects who first completed unique randomization sequences were included in the analysis. | Posted | Number | Percent of Subjects | 4 weeks |
|
|
|
| Secondary | Number of UUI Episodes Per Day - no Stimulation | 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. | 28 subjects who received no stimulation were included in the analysis. | Posted | Mean | Standard Deviation | Number of UUI episodes/ Day | 4 Weeks |
|
|
|
| Secondary | Degree of Urgency - no Stimulation | 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. | 28 subjects who received no stimulation were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Secondary | Number of Pads Used Per Day - no Stimulation | 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. | 28 subjects who received no stimulation were included in the analysis. | Posted | Mean | Standard Deviation | Pad use / day | 4 Weeks |
|
|
|
| Secondary | Global Response Assessment - no Stimulation | 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). | 28 subjects who received no stimulation were included in the analysis. | Posted | Number | Percent of Subjects | 4 Weeks |
|
|
|
| Secondary | Adverse Events - no Stimulation | 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. | 28 subjects who received no stimulation were included in the analysis. | Posted | Number | Percent of Subjects | 4 Weeks |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Cycling Parameter #1 | Subjects received Cycling Parameter #1 for approximately 4 weeks. | 0 | 30 | 4 | 30 |
| EG002 | Cycling Parameter #2 | Subjects received Cycling Parameter #2 for approximately 4 weeks. | 0 | 28 | 4 | 28 |
| EG003 | Cycling Parameter #3 | Subjects received Cycling Parameter #3 for approximately 4 weeks. | 0 | 28 | 4 | 28 |
| EG004 | No Stimulation | Subjects received no stimulation for approximately 4 weeks. | 0 | 28 | 0 | 28 |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Same |
|
| Worse |
|
| Title | Measurements |
|---|
|