- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434874
Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation
Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The StimGuard SNS System is utilized for the treatment of refractory urgency urinary incontinence as defined by the International Continence Society (ICS) Standardization of Terminology Committees Joint Report as the observation of involuntary leakage from the urethra synchronous with the sensation of a sudden, compelling desire to void that is difficult to defer. The system provides treatment by delivering small controlled electrical pulses to the sacral nerves, as these nerves have been shown to regulate the micturition cycle.
In this study, subjects will be randomized into one of two groups with a 1:1 ratio after enrollment. Subjects will either be randomized to an immediate or a delayed activation group. An intraoperative test will be performed, and all subjects will receive a permanent implant if they have an appropriate motor nerve root response without significant discomfort at 5 mA amplitude or less.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Royal Oak, Michigan, United States, 48073
- Beaumont Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A. Diagnosis of overactive bladder with urgency urinary incontinence; B. Women and men ≥ 18 years of age; C. At least 4 incontinent episodes associated with urge on a 3 day voiding diary with at least 1 each 24 hour day; D. Self-reported bladder symptoms present > 6 months; E. Self-reported failed conservative care > 6 months (i.e., pharmacology, dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.); F. Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment; G. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor; H. Normal upper urinary tract function; I. Capable of giving informed consent; J. Capable and willing to follow all study related procedures.
Exclusion Criteria:
A. Any active implantable electronic device regardless of whether stimulation is ON or OFF; B. Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period; C. Less than 1 year post partum and/or are breast-feeding; D. Neurogenic bladder; E. Botox use in bladder or pelvic floor muscles in the past six months; F. Taking alpha-blocker therapy; G. Have a PVR >150 cc at baseline; H. Primary complaint of stress urinary incontinence; I. Current urinary tract infection (UTI); J. Previous treatment with sacral neuromodulation; K. Previous treatment with tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days; L. Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures; M. Inability to operate the StimGuard SNS System; N. Diabetes with peripheral nerve involvement or have severe uncontrolled diabetes (HbA1C 8.5 or greater); O. History of coagulopathy or bleeding disorder; P. History of pelvic pain as primary diagnosis (VAS score of > 4); Q. Anatomical restrictions such that device placement is not possible; R. Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function; S. Life expectancy of less than 5 years; T. Inability to independently comprehend and complete the questionnaires and diaries; U. Unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Activation
Subjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated immediately.
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The StimGuard Sacral Nerve Stimulator System is a wirelessly powered neurostimulator for urge urinary incontinence.
This technology includes a quadripolar stimulator with an embedded receiver.
The energy source is a small, external, rechargeable transmitter, which is worn by the patient.
The transmitter sends the therapy program and power through the skin and to the receiver.
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Other: Delayed Activation
Subjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated after 90 days.
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The StimGuard Sacral Nerve Stimulator System is a wirelessly powered neurostimulator for urge urinary incontinence.
This technology includes a quadripolar stimulator with an embedded receiver.
The energy source is a small, external, rechargeable transmitter, which is worn by the patient.
The transmitter sends the therapy program and power through the skin and to the receiver.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in number of urge related incontinence episodes
Time Frame: 3 Months
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Self reported on a 3-day voiding diary
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3 Months
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Incidence and severity of adverse events
Time Frame: Up to 12 months
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Up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects with a reduction in the degree of urgency as measured by PPIUS
Time Frame: 3 Months
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Self reported on a 3-day voiding diary
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3 Months
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Proportion of subjects with a reduction in the number of voids compared to baseline
Time Frame: 3 Months
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Self reported on a 3-day voiding diary
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3 Months
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Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)
Time Frame: 3 Months
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Quesionnaire
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3 Months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects dry
Time Frame: 12 months
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Self reported on a 3-day voiding diary
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12 months
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Number of Episodes associated with urge
Time Frame: 12 months
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Self reported on a 3-day voiding diary
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12 months
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Proportion of subjects reporting improvement
Time Frame: 12 Months
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Measured by Global Response Assessment as "moderately" or "markedly improved"
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12 Months
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Improved quality of life function via Overactive Bladder Questionnaire (OAB-Q)
Time Frame: 12 Months
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Questionnaire
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12 Months
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Improved quality of life function via Idiopathic Overactive Bladder Symptom Score (iOABSS)
Time Frame: 12 Months
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Questionnaire
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12 Months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-00780
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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