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Urinary Urge IncontinenceNCT01957137

InterStim® Sacral Nerve Modulation Cycling Study

A study testing InterStim® (Device Programming) in people with Urinary Urge Incontinence, run by MedtronicNeuro at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will assess the effects of different InterStim cycling settings on urinary urge incontinence. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Urinary Urge Incontinence
What is being tested?
InterStim® (Device Programming)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
Sep 2013to Nov 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Iowa Healthcare

    Iowa City, Iowa, 52242

  • Pinellas Urology, Inc.

    St. Petersburg, Florida, 33710

  • Metro Urology

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.

Read the detailed description

This feasibility study will assess the following outcomes:

  • Voiding diaries
  • Patient reported assessments of response or satisfaction
  • Adverse events
Being tested
InterStim® (Device Programming)
Keywords
Urinary, Urge, Incontinence
Medical subject headings
Urinary Incontinence, Urge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterStim® (Device Programming)Device

Study groups in NCT01957137
Study groupRoleWhat they receive
ContinuousOtherThe device parameter will be continuous.
Receives: Device: InterStim® (Device Programming)
Cycling Parameter #1OtherThe device parameter will be cyclic program #1.
Receives: Device: InterStim® (Device Programming)
Cycling Parameter #2OtherThe device parameter will be cyclic program #2.
Receives: Device: InterStim® (Device Programming)
Cycling Parameter #3OtherThe device parameter will be cyclic program #3.
Receives: Device: InterStim® (Device Programming)
No StimulationOtherFollowing the randomized portion of the study, an assessment was conducted to estimate the effect of a month of no stimulation on incontinence.
Receives: Device: InterStim® (Device Programming)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 weeks

Secondary outcomes (8)

  1. 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.

    Measured: 4 week

  2. 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.

    Measured: 4 weeks

  3. 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.

    Measured: 4 weeks

  4. 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.

    Measured: 4 Weeks

  5. 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.

    Measured: 4 weeks

  6. 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.

    Measured: 4 Weeks

  7. 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).

    Measured: 4 Weeks

  8. 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.

    Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01957137
Sponsor's protocol ID
1670
Status last verified
Nov 2017
First submitted
25 Jun 2013
Last updated
12 Dec 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 28914707

Questions about this trial

What is this clinical trial studying?

A study testing InterStim® (Device Programming) in people with Urinary Urge Incontinence, run by MedtronicNeuro at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01957137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.

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InterStim® Sacral Nerve Modulation Cycling Study | AzTrials