Urgency FrequencyNCT01009333

InterStim Therapy Programming Study

A study testing InterStim Therapy at rate 5.2 Hz, InterStim Therapy at rate 14 Hz and InterStim Therapy in people with Urgency Frequency and Urinary Urge Incontinence, run by MedtronicNeuro at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Urgency Frequency, Urinary Urge Incontinence
What is being tested?: InterStim Therapy at rate 5.2 Hz, InterStim Therapy at rate 14 Hz and InterStim Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Nov 2010
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 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

Show all 10Show fewer

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

Who cannot join

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

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Kenneth Peters, MD
Royal Oak, Michigan, 48073

Other trials in United States

About this study

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.

Conditions: Urgency Frequency, Urinary Urge Incontinence
Being tested: InterStim Therapy at rate 5.2 Hz, InterStim Therapy at rate 14 Hz, InterStim Therapy
Keywords: urgency frequency, urinary urge incontinence, InterStim Therapy
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 Therapy at rate 5.2 HzDevice
All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
InterStim Therapy at rate 14 HzDevice
All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
InterStim TherapyDevice
All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.

Study groups in NCT01009333
Study group	Role	What they receive
Low InterStim rate setting at 5.2 Hz	Experimental	Not described Receives: Device: InterStim Therapy at rate 5.2 Hz
Medium InterStim rate setting at 14 Hz	Experimental	Not described Receives: Device: InterStim Therapy at rate 14 Hz
High InterStim rate setting at 25 Hz	Experimental	Not described Receives: Device: InterStim Therapy

What is being measured

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

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.
Measured: three weeks

Secondary outcomes (2)

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.
Measured: three weeks
Number of Pads Per Day
In a diary, subjects are asked to provide number of pads they used per day.
Measured: three weeks

Timeline

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

Nov 2009Nov 2010

First posted6 Nov 2009 (estimated)
Study startNov 2009
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urgency FrequencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01009333
Sponsor's protocol ID: 1650
Status last verified: May 2013
First submitted: 2 Nov 2009
Last updated: 27 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
Overactive Bladder, Urinary Urgency Incontinence
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Cefar URO - Symptomatic Treatment of Overactive Bladder
Overactive Bladder (OAB), Refractory Overactive Bladder
Not yet recruiting
Low-Intensity Shock Wave Therapy for Refractory Overactive Bladder in Women
Urinary Bladder, Overactive
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms

All Urgency Frequency trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: InterStim Therapy Programming Study
ClinicalTrials.gov ID: NCT01009333
Acronym / sponsor ID: 1650
Conditions: Urgency Frequency, Urinary Urge Incontinence
Keywords: urgency frequency, urinary urge incontinence, InterStim Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 6 Nov 2009 (estimated)
Results: Posted 2 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Low InterStim rate setting at 5.2 Hz	Experimental	Device: InterStim Therapy at rate 5.2 Hz
Medium InterStim rate setting at 14 Hz	Experimental	Device: InterStim Therapy at rate 14 Hz
High InterStim rate setting at 25 Hz	Experimental	Device: InterStim Therapy

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (18 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InterStim Therapy at rate 5.2 HzAll subjects enrolled in this study were programmed to this rate setting for a 1-week period.	Device	Low InterStim rate setting at 5.2 Hz
InterStim Therapy at rate 14 HzAll subjects enrolled in this study were programmed to this rate setting for a 1-week period.	Device	Medium InterStim rate setting at 14 Hz
InterStim TherapyAll subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.	Device	High InterStim rate setting at 25 Hz

Primary outcome

Number of Urinary Incontinent Episodes Per Day
Time frame: 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.

2 secondary outcomes

Number of Voids Per Day
Time frame: three weeks
Number of Pads Per Day
Time frame: three weeks

Results and safety

Results posted to the registry on 2 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Start at 5.2 Hz, Then 14 Hz, Then 25 Hz	2	2
Start at 5.2 Hz, Then 25 Hz, Then 14 Hz	3	3
Start at 14 Hz, Then 5.2 Hz, Then 25 Hz	2	2
Start at 14 Hz, Then 25 Hz, Then 5.2 Hz	2	2
Start at 25 Hz, Then 5.2 Hz, Then 14 Hz	2	2
Start at 25 Hz, Then 14 Hz, Then 5.2 Hz	2	2

Primary outcome: Number of Urinary Incontinent Episodes Per Day

Time frame: three weeks. Mean (Standard Deviation). Unit: Episodes Per Day

Measure	Low InterStim Rate Setting at 5.2 Hz n = 12	Medium InterStim Rate Setting at 14 Hz n = 12	High InterStim Rate Setting at 25 Hz n = 12
Value	3.83 (2.27)	2.37 (1.83)	2.82 (2.1)

Low InterStim Rate Setting at 5.2 Hz vs High InterStim Rate Setting at 25 Hz: p = 0.008, Mixed Models Analysis

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low InterStim Rate Setting at 5.2 Hz	0 of 13 (0%)	6 of 13 (46.2%)	Not reported
Medium InterStim Rate Setting at 14 Hz	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
High InterStim Rate Setting at 25 Hz	0 of 12 (0%)	7 of 12 (58.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Urgency Frequency

Recruiting
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
Overactive Bladder, Urinary Urgency Incontinence
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Cefar URO - Symptomatic Treatment of Overactive Bladder
Overactive Bladder (OAB), Refractory Overactive Bladder
Not yet recruiting
Low-Intensity Shock Wave Therapy for Refractory Overactive Bladder in Women
Urinary Bladder, Overactive
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maureen McGuire, Ph.D. study director

MedtronicNeuro

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 May 2012). 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 Incontinent Episodes Per Day (time frame: three 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 NCT01009333.

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 27 May 2013.