InterStim Amplitude Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
2. Female subjects 18 years of age or older
3. Candidate for InterStim Lead Placement
4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)
5. Willing and able to provide signed and dated informed consent
6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication

Exclusion Criteria

1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
2. History of diabetes unless the diabetes is well-controlled through diet and/or medications
3. Symptomatic urinary tract infection (UTI)
4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
6. Implanted with a neurostimulator, pacemaker, or defibrillator
7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy
8. Women who are pregnant or planning to become pregnant
9. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements
10. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective in the study is to explore the effect of three different a<br /><br>mplitude settings (50% of <br /><br>sensory threshold, 80% of sensory threshold and sensory threshold) on number of <br /><br>UUI episodes per day</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective of this study is quality of life (ICIQ<br /><br>OABqol) for the three different amplitude settings. <br /><br><br /><br>Additional measures include: <br /><br>Safety <br /><br>Patient Global Impression of Improvement (PGII) *<br /><br>Urinary Frequency </p><br>