An interventional study of InterStim® (Device Programming) in Urinary Urge Incontinence, sponsored by MedtronicNeuro. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by MedtronicNeuro (part of Medtronic) · Not applicable, Interventional, and Treatment
The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.
This feasibility study will assess the following outcomes:
206 studies on the registry are indexed under Urinary Incontinence, Urge; 41 are open to participants now.
This study's enrollment of 30 is below the median of 75 across 158 interventional studies indexed under Urinary Incontinence, Urge.
Browse Urinary Incontinence, Urge studies →MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
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Exclusion Criteria:
The device parameter will be continuous.
Device: InterStim® (Device Programming)
The device parameter will be cyclic program #1.
Device: InterStim® (Device Programming)
The device parameter will be cyclic program #2.
Device: InterStim® (Device Programming)
The device parameter will be cyclic program #3.
Device: InterStim® (Device Programming)
Following the randomized portion of the study, an assessment was conducted to estimate the effect of a month of no stimulation on incontinence.
Device: InterStim® (Device Programming)
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
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
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
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
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
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
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
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
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
Thirty subjects were enrolled into the study from Sept 10, 2013 through May 22, 2015 from 3 US centers.
| Milestone | All Study Participants |
|---|---|
| Started | 30 |
| Continuous stimulation | 29 |
| Cycling parameter #1 | 30 |
| Cycling parameter #2 | 28 |
| Cycling parameter #3 | 28 |
| Completed | 28 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | All Study Participants |
|---|---|
| Started | 28 |
| Completed | 28 |
| Not completed | 0 |
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.
| Number of UUI episodes/ Day | Continuous | Cycling Parameter #1 | Cycling Parameter #2 | Cycling Parameter #3 |
|---|---|---|---|---|
| Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | 1.64 ± 1.40 | 1.82 ± 1.97 | 1.44 ± 1.20 | 1.76 ± 1.76 |
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.
| units on a scale | Continuous | Cycling Parameter #1 | Cycling Parameter #2 | Cycling Parameter #3 |
|---|---|---|---|---|
| Degree of Urgency - Randomized Portion | 1.83 (1.48 to 2.19) | 1.80 (1.44 to 2.16) | 1.54 (1.17 to 1.91) | 1.65 (1.29 to 2.01) |
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.
| Pads per day | Continuous | Cycling Parameter #1 | Cycling Parameter #2 | Cycling Parameter #3 |
|---|---|---|---|---|
| Number of Pads Used Per Day - Randomized Portion | 1.10 (0.67 to 1.52) | 1.16 (0.73 to 1.58) | 1.17 (0.74 to 1.59) | 1.20 (0.78 to 1.63) |
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.
| Percent of Subjects | Continuous | Cycling Parameter #1 | Cycling Parameter #2 | Cycling Parameter #3 |
|---|---|---|---|---|
| Better | 29 | 38 | 54 | 42 |
| Same | 25 | 21 | 17 | 38 |
| Worse | 46 | 42 | 29 | 21 |
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.
| Number of UUI episodes/ Day | No Stimulation |
|---|---|
| Number of UUI Episodes Per Day - no Stimulation | 1.97 ± 2.04 |
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.
| units on a scale | No Stimulation |
|---|---|
| Degree of Urgency - no Stimulation | 1.77 ± 0.64 |
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.
| Pad use / day | No Stimulation |
|---|---|
| Number of Pads Used Per Day - no Stimulation | 1.23 ± 1.22 |
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).
| Percent of Subjects | No Stimulation |
|---|---|
| Better | 43 |
| Same | 21 |
| Worse | 36 |
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.
| Percent of Subjects | No Stimulation |
|---|---|
| Adverse Events - no Stimulation | 10.7 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous | — | 0/29 (0%) | 1/29 (3.4%) |
| Cycling Parameter #1 | — | 0/30 (0%) | 4/30 (13.3%) |
| Cycling Parameter #2 | — | 0/28 (0%) | 4/28 (14.3%) |
| Cycling Parameter #3 | — | 0/28 (0%) | 4/28 (14.3%) |
| No Stimulation | — | 0/28 (0%) | 0/28 (0%) |
| Event | Continuous | Cycling Parameter #1 | Cycling Parameter #2 | Cycling Parameter #3 | No Stimulation |
|---|---|---|---|---|---|
| Device stimulation issueSurgical and medical procedures | 1/29 | 4/30 | 4/28 | 4/28 | 0/28 |
Baseline descriptions provided were based on 24 subjects who first finished their randomized sequences who were included in the primary analysis.
| Age, Continuous(years) | Subjects Who First Finished Unique Randomization Sequences |
|---|---|
| Mean | 64.0 ± 13.5 |
| Sex: Female, Male(Participants) | Subjects Who First Finished Unique Randomization Sequences |
|---|---|
| Female | 24 |
| Male | 0 |
| Years implanted with InterStim therapy(years) | Subjects Who First Finished Unique Randomization Sequences |
|---|---|
| Mean | 2.8 ± 3.1 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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