InterStim Therapy Programming Study

Not Applicable

Completed

Conditions: Urgency Frequency
Urinary Urge Incontinence

Interventions: Device: InterStim Therapy at rate 5.2 Hz
Device: InterStim Therapy at rate 14 Hz
Device: InterStim Therapy

Registration Number: NCT01009333

Lead Sponsor: MedtronicNeuro

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 13

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low InterStim rate setting at 5.2 Hz	InterStim Therapy at rate 5.2 Hz	-
Medium InterStim rate setting at 14 Hz	InterStim Therapy at rate 14 Hz	-
High InterStim rate setting at 25 Hz	InterStim Therapy	-

Primary Outcome Measures

Name	Time	Method
Number of Urinary Incontinent Episodes Per Day	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

Name	Time	Method
Number of Voids Per Day	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.
Number of Pads Per Day	three weeks	In a diary, subjects are asked to provide number of pads they used per day.