InterStim® Sacral Nerve Modulation Cycling Study

Study Overview
=================
Brief Summary
-----------------
The study will assess the effects of different InterStim cycling settings on urinary urge incontinence.

Detailed Description
-----------------
This feasibility study will assess the following outcomes: Voiding diaries Patient reported assessments of response or satisfaction Adverse events

Official Title
-----------------
InterStim® Sacral Nerve Modulation Cycling Study

Conditions
-----------------
Urinary Urge Incontinence

Intervention / Treatment
-----------------
* Device: InterStim® (Device Programming)


Participation Criteria
=================
Eligibility 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 at S3 as determined by sensory or motor responses or x-ray or fluoroscopy Currently showing some efficacy with an InterStim device but has the potential to be optimized per the opinion of the Investigator Primary diagnosis before InterStim implant is urinary urge incontinence. Must be willing to maintain her current regimen (dosage and frequency) of any overactive bladder (OAB) medication (anticholinergic, antimuscarinic or Myrbetriq (Mirabegron)) or tricyclic antidepression medication over the study duration, if applicable. Female subject 18 years of age or older Willing and able to accurately complete voiding diaries and questionnaires, attend visits (within the visit windows +7 days), and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study Have had no more than one (InterStim) reprogramming at or within 28 days at or prior to randomization Able to consent to participate by signing the Informed Consent Form Exclusion Criteria: History of Multiple sclerosis History of Reiter's syndrome History of spinal cord injury or a cerebral vascular accident (CVA) History of diabetes unless the diabetes is well-controlled through diet and/or medications Active symptomatic urinary tract infection (UTI) Stress incontinence as the primary diagnosis Urgency frequency as a primary diagnosis Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary 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 diathermy, microwave exposure, high output ultrasonic exposure, RF energy exposure, or MRI scans not included within the scanning conditions provided within the MRI Guidelines for InterStim Therapy neurostimulation systems. Have an anticipated system modification within the next 5 months Women who are pregnant or planning to become pregnant (women of child-bearing 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 (or designee) to determine if a potential subject who plans to enroll in an investigational device or drug trial, or is currently enrolled in an investigational device or drug trial is eligible for this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous<br>The device parameter will be continuous. | Device: InterStim® (Device Programming)<br> <br> |
| Other: Cycling Parameter #1<br>The device parameter will be cyclic program #1. | Device: InterStim® (Device Programming)<br> <br> |
| Other: Cycling Parameter #2<br>The device parameter will be cyclic program #2. | Device: InterStim® (Device Programming)<br> <br> |
| Other: Cycling Parameter #3<br>The device parameter will be cyclic program #3. | Device: InterStim® (Device Programming)<br> <br> |
| Other: No Stimulation<br>Following the randomized portion of the study, an assessment was conducted to estimate the effect of a month of no stimulation on incontinence. | Device: InterStim® (Device Programming)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion | Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Urgency - Randomized Portion | Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period. | 4 week | 
| Number of Pads Used Per Day - Randomized Portion | Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period. | 4 weeks | 
| Global Response Assessment (GRA) - Randomized Portion | Summary statistics of GRA at different cycling settings are provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved). Percentages of subjects reported worse, same or better under each cycling setting since starting the study are presented. | 4 weeks | 
| Number of UUI Episodes Per Day - no Stimulation | UUI episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period. | 4 Weeks | 
| Degree of Urgency - no Stimulation | Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period. | 4 weeks | 
| Number of Pads Used Per Day - no Stimulation | Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period. | 4 Weeks | 
| Global Response Assessment - no Stimulation | Summary of GRA under no stimulation setting is provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved). | 4 Weeks | 
| Adverse Events - no Stimulation | Summary of adverse device effects when subjects were under no stimulation is provided. Percentage of subjects experiencing any type of Adverse Device Effect under no stimulation is presented. | 4 Weeks | 

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