- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01009333
InterStim Therapy Programming Study
May 17, 2013 updated by: MedtronicNeuro
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Royal Oak, Michigan, United States, 48073
- Kenneth Peters, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low InterStim rate setting at 5.2 Hz
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All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
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EXPERIMENTAL: Medium InterStim rate setting at 14 Hz
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All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
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EXPERIMENTAL: High InterStim rate setting at 25 Hz
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All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
three weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Voids Per Day
Time Frame: 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.
|
three weeks
|
Number of Pads Per Day
Time Frame: three weeks
|
In a diary, subjects are asked to provide number of pads they used per day.
|
three weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Maureen McGuire, Ph.D., MedtronicNeuro
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
November 2, 2009
First Submitted That Met QC Criteria
November 5, 2009
First Posted (ESTIMATE)
November 6, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
May 27, 2013
Last Update Submitted That Met QC Criteria
May 17, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1650
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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