Urgency Frequency, Urinary Urge Incontinence
Conditions
Keywords
urgency frequency, urinary urge incontinence, InterStim Therapy
Brief summary
This study assessed the effect of different InterStim rate settings on voiding diary outcomes. Specifically, the study evaluated how 3 different rate settings affected the number of urinary incontinent episodes per day collected through a voiding diary. The study also evaluated how the 3 different rate settings affected other voiding diary measures including number of voids per day, degree of urgency before each void, number of pads used per day, and number of fecal incontinent episodes, questionnaires, and adverse events.
Interventions
DEVICEInterStim Therapy at rate 5.2 Hz
All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
DEVICEInterStim Therapy at rate 14 Hz
All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
DEVICEInterStim Therapy
All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 in S2, S3, or S4 * Diagnosis before InterStim implant included urgency frequency (an average of 8 or more voids per day) and any amount of urinary urge incontinence over the voiding diary reporting period. The diary reporting period must be at least 2 days. * Able to tolerate (ie, no complaint of pain or discomfort) acute high InterStim rate setting * Able to tolerate (ie, no complaint of pain or discomfort) acute medium InterStim rate setting * Able to tolerate (ie, no complaint of pain or discomfort) acute low InterStim rate setting * Must be willing to maintain their current regimen (dosage and frequency) of any overactive bladder medication (anticholinergic or antimuscarinic) or tricyclic antidepression medication over the study duration * Female subject 18 years of age or older * Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study. * Able to consent to participate by signing the Informed Consent Form
Exclusion criteria
* Multiple sclerosis * Reiter's syndrome * Exclude diabetics unless the subject's diabetes is well-controlled with diet or medication * History of spinal cord injury or a cerebral vascular accident (CVA) * Active symptomatic urinary tract infection (UTI) * Stress incontinence as the primary diagnosis * Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/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 MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure * Have an anticipated system modification within the next 1 month * Women who are pregnant or planning to become pregnant or women of child-bearing potential who are not using a medically-acceptable method of birth control. Women of child-bearing age 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 to determine if a potential subject who plans to enroll in another 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 Incontinent Episodes Per Day | three weeks | In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Voids Per Day | three weeks | In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day. |
| Number of Pads Per Day | three weeks | In a diary, subjects are asked to provide number of pads they used per day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 61.9 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 13 | 5 / 12 | 7 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Urinary Incontinent Episodes Per Day
In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.
Time frame: three weeks
Population: Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low InterStim Rate Setting at 5.2 Hz | Number of Urinary Incontinent Episodes Per Day | 3.83 Episodes Per Day | Standard Deviation 2.27 |
| Medium InterStim Rate Setting at 14 Hz | Number of Urinary Incontinent Episodes Per Day | 2.37 Episodes Per Day | Standard Deviation 1.83 |
| High InterStim Rate Setting at 25 Hz | Number of Urinary Incontinent Episodes Per Day | 2.82 Episodes Per Day | Standard Deviation 2.1 |
p-value: 0.008Mixed Models Analysis
Secondary
Number of Pads Per Day
In a diary, subjects are asked to provide number of pads they used per day.
Time frame: three weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low InterStim Rate Setting at 5.2 Hz | Number of Pads Per Day | 2.61 Pads Per Day | Standard Deviation 1.64 |
| Medium InterStim Rate Setting at 14 Hz | Number of Pads Per Day | 1.84 Pads Per Day | Standard Deviation 1.43 |
| High InterStim Rate Setting at 25 Hz | Number of Pads Per Day | 1.94 Pads Per Day | Standard Deviation 1.61 |
p-value: 0.04Mixed Models Analysis
Secondary
Number of Voids Per Day
In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.
Time frame: three weeks
Population: Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low InterStim Rate Setting at 5.2 Hz | Number of Voids Per Day | 9.33 Voids Per Day | Standard Deviation 2.08 |
| Medium InterStim Rate Setting at 14 Hz | Number of Voids Per Day | 9.36 Voids Per Day | Standard Deviation 2.34 |
| High InterStim Rate Setting at 25 Hz | Number of Voids Per Day | 9.57 Voids Per Day | Standard Deviation 2.28 |
p-value: 0.589Mixed Models Analysis