InterStim® Amplitude Study

Study Overview
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Brief Summary
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This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).

Detailed Description
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This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.

Official Title
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InterStim® Amplitude Study

Conditions
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Urinary Urge Incontinence

Intervention / Treatment
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* Device: InterStim Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes Female subjects 18 years of age or older Candidate for InterStim Lead Placement 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) Willing and able to provide signed and dated informed consent Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication Exclusion Criteria: Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury History of diabetes unless the diabetes is well-controlled through diet and/or medications Symptomatic urinary tract infection (UTI) Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study Implanted with a neurostimulator, pacemaker, or defibrillator Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy Women who are pregnant or planning to become pregnant Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amplitude Setting #1<br>InterStim Therapy will be set to amplitude parameter #1. | Device: InterStim Therapy<br>* Device Programming<br>|
| Experimental: Amplitude Setting #2<br>InterStim Therapy will be set to amplitude parameter #2. | Device: InterStim Therapy<br>* Device Programming<br>|
| Experimental: Amplitude Setting #3<br>InterStim Therapy will be set to amplitude parameter #3. | Device: InterStim Therapy<br>* Device Programming<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference. The four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. Interference was measured on a scale from 0-10. A positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary, Incontinence