InterStim Therapy Programming Study

• ClinicalTrials.gov Identifier: NCT01009333
• Recruitment Status: Completed
• First Posted: November 6, 2009
• Results First Posted: May 2, 2012
• Last Update Posted: May 27, 2013
• Sponsor: MedtronicNeuro
• Information provided by (Responsible Party): MedtronicNeuro

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Urgency Frequency; Urinary Urge Incontinence	Device: InterStim Therapy at rate 5.2 Hz; Device: InterStim Therapy at rate 14 Hz; Device: InterStim Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Official Title: InterStim Therapy Programming Study
• Study Start Date: November 2009
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low InterStim rate setting at 5.2 Hz	Device: InterStim Therapy at rate 5.2 Hz; All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
Experimental: Medium InterStim rate setting at 14 Hz	Device: InterStim Therapy at rate 14 Hz; All subjects enrolled in this study were programmed to this rate setting for a 1-week period.
Experimental: High InterStim rate setting at 25 Hz	Device: InterStim Therapy; All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. Number of Pads Per Day [ Time Frame: three weeks ]
   In a diary, subjects are asked to provide number of pads they used per day.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Michigan

Kenneth Peters, MD

Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

MedtronicNeuro

Investigators

• Study Director: Maureen McGuire, Ph.D.; MedtronicNeuro

More Information

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT01009333
• Other Study ID Numbers: 1650
• First Posted: November 6, 2009
• Results First Posted: May 2, 2012
• Last Update Posted: May 27, 2013
• Last Verified: May 2013

Keywords provided by MedtronicNeuro:

urgency frequency; urinary urge incontinence; InterStim Therapy

Additional relevant MeSH terms:

Urinary Incontinence, Urge; Urinary Incontinence; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations