Urinary Urge Incontinence
Conditions
Keywords
Urinary, Urge, Incontinence
Brief summary
The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.
Detailed description
This feasibility study will assess the following outcomes: * Voiding diaries * Patient reported assessments of response or satisfaction * Adverse events
Interventions
DEVICEInterStim® (Device Programming)
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months 2. Implanted with tined lead models 3889 or 3093 3. Tined lead is located at S3 as determined by sensory or motor responses or x-ray or fluoroscopy 4. Currently showing some efficacy with an InterStim device but has the potential to be optimized per the opinion of the Investigator 5. Primary diagnosis before InterStim implant is urinary urge incontinence. 6. 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. 7. Female subject 18 years of age or older 8. 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 9. Have had no more than one (InterStim) reprogramming at or within 28 days at or prior to randomization 10. Able to consent to participate by signing the Informed Consent Form
Exclusion criteria
11. History of Multiple sclerosis 12. History of Reiter's syndrome 13. History of spinal cord injury or a cerebral vascular accident (CVA) 14. History of diabetes unless the diabetes is well-controlled through diet and/or medications 15. Active symptomatic urinary tract infection (UTI) 16. Stress incontinence as the primary diagnosis 17. Urgency frequency as a primary diagnosis 18. Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary diagnosis 19. Interstitial cystitis as the primary diagnosis 20. Urinary retention as the primary diagnosis 21. Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study 22. Bilateral lead placement 23. Have other implantable neurostimulator, pacemaker, or defibrillator 24. 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. 25. Have an anticipated system modification within the next 5 months 26. 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) 27. 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) 28. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol. 29. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pads Used Per Day - Randomized Portion | 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. |
| Global Response Assessment (GRA) - Randomized Portion | 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. |
| Number of UUI Episodes Per Day - no Stimulation | 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. |
| Degree of Urgency - Randomized Portion | 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. |
| Number of Pads Used Per Day - no Stimulation | 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. |
| Global Response Assessment - no Stimulation | 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). |
| Adverse Events - no Stimulation | 4 Weeks | 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. |
| Degree of Urgency - no Stimulation | 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. |
Countries
United States
Participant flow
Recruitment details
Thirty subjects were enrolled into the study from Sept 10, 2013 through May 22, 2015 from 3 US centers.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Randomized Portion | Adverse Event | 1 |
| Randomized Portion | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Subjects Who First Finished Unique Randomization Sequences |
|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 13.5 |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
| Years implanted with InterStim therapy | 2.8 years STANDARD_DEVIATION 3.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 29 | 4 / 30 | 4 / 28 | 4 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 | 0 / 28 | 0 / 28 | 0 / 28 |
Outcome results
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.
Time frame: 4 weeks
Population: 24 subjects who first completed the unique randomization sequences were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous | Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | 1.64 Number of UUI episodes/ Day | Standard Deviation 1.4 |
| Cycling Parameter #1 | Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | 1.82 Number of UUI episodes/ Day | Standard Deviation 1.97 |
| Cycling Parameter #2 | Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | 1.44 Number of UUI episodes/ Day | Standard Deviation 1.2 |
| Cycling Parameter #3 | Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | 1.76 Number of UUI episodes/ Day | Standard Deviation 1.76 |
p-value: 0.3773Mixed Models Analysis
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.
Time frame: 4 Weeks
Population: 28 subjects who received no stimulation were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous | Adverse Events - no Stimulation | 10.7 Percent of Subjects |
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.
Time frame: 4 weeks
Population: 28 subjects who received no stimulation were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous | Degree of Urgency - no Stimulation | 1.77 units on a scale | Standard Deviation 0.64 |
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.
Time frame: 4 week
Population: 24 subjects who first completed unique randomization sequences were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Continuous | Degree of Urgency - Randomized Portion | 1.83 units on a scale |
| Cycling Parameter #1 | Degree of Urgency - Randomized Portion | 1.80 units on a scale |
| Cycling Parameter #2 | Degree of Urgency - Randomized Portion | 1.54 units on a scale |
| Cycling Parameter #3 | Degree of Urgency - Randomized Portion | 1.65 units on a scale |
p-value: 0.2396Mixed Models Analysis
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.
Time frame: 4 weeks
Population: 24 subjects who first completed unique randomization sequences were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Continuous | Global Response Assessment (GRA) - Randomized Portion | Same | 25 Percent of Subjects |
| Continuous | Global Response Assessment (GRA) - Randomized Portion | Worse | 46 Percent of Subjects |
| Continuous | Global Response Assessment (GRA) - Randomized Portion | Better | 29 Percent of Subjects |
| Cycling Parameter #1 | Global Response Assessment (GRA) - Randomized Portion | Same | 21 Percent of Subjects |
| Cycling Parameter #1 | Global Response Assessment (GRA) - Randomized Portion | Worse | 42 Percent of Subjects |
| Cycling Parameter #1 | Global Response Assessment (GRA) - Randomized Portion | Better | 38 Percent of Subjects |
| Cycling Parameter #2 | Global Response Assessment (GRA) - Randomized Portion | Better | 54 Percent of Subjects |
| Cycling Parameter #2 | Global Response Assessment (GRA) - Randomized Portion | Same | 17 Percent of Subjects |
| Cycling Parameter #2 | Global Response Assessment (GRA) - Randomized Portion | Worse | 29 Percent of Subjects |
| Cycling Parameter #3 | Global Response Assessment (GRA) - Randomized Portion | Same | 38 Percent of Subjects |
| Cycling Parameter #3 | Global Response Assessment (GRA) - Randomized Portion | Worse | 21 Percent of Subjects |
| Cycling Parameter #3 | Global Response Assessment (GRA) - Randomized Portion | Better | 42 Percent of Subjects |
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).
Time frame: 4 Weeks
Population: 28 subjects who received no stimulation were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Continuous | Global Response Assessment - no Stimulation | Better | 43 Percent of Subjects |
| Continuous | Global Response Assessment - no Stimulation | Same | 21 Percent of Subjects |
| Continuous | Global Response Assessment - no Stimulation | Worse | 36 Percent of Subjects |
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.
Time frame: 4 Weeks
Population: 28 subjects who received no stimulation were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous | Number of Pads Used Per Day - no Stimulation | 1.23 Pad use / day | Standard Deviation 1.22 |
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.
Time frame: 4 weeks
Population: 24 subjects who first completed unique randomization sequences were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Continuous | Number of Pads Used Per Day - Randomized Portion | 1.10 Pads per day |
| Cycling Parameter #1 | Number of Pads Used Per Day - Randomized Portion | 1.16 Pads per day |
| Cycling Parameter #2 | Number of Pads Used Per Day - Randomized Portion | 1.17 Pads per day |
| Cycling Parameter #3 | Number of Pads Used Per Day - Randomized Portion | 1.20 Pads per day |
p-value: 0.8874Mixed Models Analysis
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.
Time frame: 4 Weeks
Population: 28 subjects who received no stimulation were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous | Number of UUI Episodes Per Day - no Stimulation | 1.97 Number of UUI episodes/ Day | Standard Deviation 2.04 |