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CompletedNCT01009333Updated May 27, 2013Results posted

InterStim Therapy Programming Study

An interventional study of InterStim Therapy at rate 5.2 Hz and InterStim Therapy at rate 14 Hz in Urgency Frequency and Urinary Urge Incontinence, sponsored by MedtronicNeuro. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-27.

Sponsored by MedtronicNeuro (part of Medtronic) · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Urgency Frequency
  • Urinary Urge Incontinence

Keywords

  • urgency frequency
  • urinary urge incontinence
  • InterStim Therapy
03

In context

Urinary Incontinence, Urge

206 studies on the registry are indexed under Urinary Incontinence, Urge; 40 are open to participants now.

This study's enrollment of 13 is below the median of 75 across 158 interventional studies indexed under Urinary Incontinence, Urge.

Browse Urinary Incontinence, Urge studies →

Lead sponsor

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.

Browse MedtronicNeuro studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Low InterStim rate setting at 5.2 Hz

    Device: InterStim Therapy at rate 5.2 Hz

  • Experimental
    Medium InterStim rate setting at 14 Hz

    Device: InterStim Therapy at rate 14 Hz

  • Experimental
    High InterStim rate setting at 25 Hz

    Device: InterStim Therapy

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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Number of Pads Per Day

    In a diary, subjects are asked to provide number of pads they used per day.

    Time frame: three weeks

07

Results

Posted May 2, 2012

Participant flow

Week 1
Participant flow — Week 1
MilestoneStart at 5.2 Hz, Then 14 Hz, Then 25 HzStart at 5.2 Hz, Then 25 Hz, Then 14 HzStart at 14 Hz, Then 5.2 Hz, Then 25 HzStart at 14 Hz, Then 25 Hz, Then 5.2 HzStart at 25 Hz, Then 5.2 Hz, Then 14 HzStart at 25 Hz, Then 14 Hz, Then 5.2 Hz
Started232222
Completed232222
Not completed000000
Week 2
Participant flow — Week 2
MilestoneStart at 5.2 Hz, Then 14 Hz, Then 25 HzStart at 5.2 Hz, Then 25 Hz, Then 14 HzStart at 14 Hz, Then 5.2 Hz, Then 25 HzStart at 14 Hz, Then 25 Hz, Then 5.2 HzStart at 25 Hz, Then 5.2 Hz, Then 14 HzStart at 25 Hz, Then 14 Hz, Then 5.2 Hz
Started222222
Completed222222
Not completed000000
Week 3
Participant flow — Week 3
MilestoneStart at 5.2 Hz, Then 14 Hz, Then 25 HzStart at 5.2 Hz, Then 25 Hz, Then 14 HzStart at 14 Hz, Then 5.2 Hz, Then 25 HzStart at 14 Hz, Then 25 Hz, Then 5.2 HzStart at 25 Hz, Then 5.2 Hz, Then 14 HzStart at 25 Hz, Then 14 Hz, Then 5.2 Hz
Started222222
Completed222222
Not completed000000

Outcome measures

PrimaryNumber 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
Reported as:
Mean · Episodes Per Day
Number of Urinary Incontinent Episodes Per Day
Episodes Per DayLow InterStim Rate Setting at 5.2 HzMedium InterStim Rate Setting at 14 HzHigh InterStim Rate Setting at 25 Hz
Number of Urinary Incontinent Episodes Per Day3.83 ± 2.272.37 ± 1.832.82 ± 2.1
Statistical analysis
  • Low InterStim Rate Setting at 5.2 Hz vs High InterStim Rate Setting at 25 Hz · Mixed Models Analysis · p = 0.008
SecondaryNumber 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
Reported as:
Mean · Voids Per Day
Number of Voids Per Day
Voids Per DayLow InterStim Rate Setting at 5.2 HzMedium InterStim Rate Setting at 14 HzHigh InterStim Rate Setting at 25 Hz
Number of Voids Per Day9.33 ± 2.089.36 ± 2.349.57 ± 2.28
Statistical analysis
  • Low InterStim Rate Setting at 5.2 Hz vs High InterStim Rate Setting at 25 Hz · Mixed Models Analysis · p = 0.589
SecondaryNumber of Pads Per Day

In a diary, subjects are asked to provide number of pads they used per day.

Time frame:
three weeks
Reported as:
Mean · Pads Per Day
Number of Pads Per Day
Pads Per DayLow InterStim Rate Setting at 5.2 HzMedium InterStim Rate Setting at 14 HzHigh InterStim Rate Setting at 25 Hz
Number of Pads Per Day2.61 ± 1.641.84 ± 1.431.94 ± 1.61
Statistical analysis
  • Low InterStim Rate Setting at 5.2 Hz vs High InterStim Rate Setting at 25 Hz · Mixed Models Analysis · p = 0.04

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Low InterStim Rate Setting at 5.2 Hz—0/13 (0%)6/13 (46.2%)
Medium InterStim Rate Setting at 14 Hz—0/12 (0%)5/12 (41.7%)
High InterStim Rate Setting at 25 Hz—0/12 (0%)7/12 (58.3%)
Most frequent other events
Showing 10 of 17
Most frequent other events
EventLow InterStim Rate Setting at 5.2 HzMedium InterStim Rate Setting at 14 HzHigh InterStim Rate Setting at 25 Hz
Urinary incontinenceRenal and urinary disorders0/132/120/12
Hypertonic bladderRenal and urinary disorders2/130/120/12
Bladder discomfortRenal and urinary disorders1/130/121/12
BronchitisInfections and infestations0/131/120/12
Change in sensation of stimulationRenal and urinary disorders0/131/120/12
ConstipationGastrointestinal disorders0/130/121/12
Faecal incontinenceGastrointestinal disorders0/131/120/12
HypertensionVascular disorders0/131/120/12
Muscle contractions involuntaryNervous system disorders0/130/121/12
Muscle spasmsMusculoskeletal and connective tissue disorders0/130/121/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Study Participants
<=18 years0
Between 18 and 65 years10
>=65 years2
Age Continuous
Age Continuous(years)All Study Participants
Mean61.9 ± 6.9
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female12
Male0
Region of Enrollment
Region of Enrollment(participants)All Study Participants
United States12
08

Study locations

1 site
  • Kenneth Peters, MD
    Royal Oak, Michigan 48073, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01009333
Lead sponsor
MedtronicNeuro
Responsible party
Sponsor
First posted
Nov 6, 2009
Start date
Nov 2009
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
May 2, 2012
Last update
May 27, 2013

Study contacts

Maureen McGuire, Ph.D.
study director · MedtronicNeuro

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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