Direct Full-stage Implantation of Sacral Neuromodulation

Study Overview
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Brief Summary
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The purpose of this investigator-initiated study is to investigate the efficacy and costs of direct full stage sacral neuromodulation in patients with overactive bladder. Patients with refractory OAB and urge urinary incontinence will undergo direct full stage implantation and be followed for a period of 6 months to monitor symptom improvement with voiding diaries and validated questionnaires preoperatively and postoperatively. Therapeutic and adverse outcomes will be evaluated. The use of medical resources and time off of work will be analyzed as well. This will be a descriptive study with no additional arms or randomization.

Official Title
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Direct Full-stage Implantation of Sacral Neuromodulation

Conditions
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Urinary Bladder, Overactive, Urge Incontinence

Intervention / Treatment
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* Device: full stage implantation of sacral neuromodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >18 years of age Female gender Refractory overactive bladder: wet failing treatment with two or more anticholinergic and/or beta-3 agonist agents Willing to stop treatment with anticholingeric and/or beta-3 agonist agents during the study period (2 week washout period preoperatively and 6 months postoperative) Willing and able to complete study questionnaires, use Medtronic device programmer, return for scheduled follow-up appointments Surgical candidate able to hold antiplatelet or anticoagulation prior to surgery Health insurance provider that will cover full-stage implantation Exclusion Criteria: Age <18 Pregnant or planning to become pregnant Male gender Unable or unwilling to stop anticholingeric and/or beta-3 agonist agents during the study period Treatment with botulinum toxin within last 6 months Recent surgery for stress urinary incontinence or pelvic organ prolapse within last 6 months Severe pelvic organ prolapse Post-void residual >150 ml Symptomatic or recurrent urinary tract infection Neurologic disorders: cerebrovascular accident with neurologic deficits, Parkinson's, multiple sclerosis, spinal cord injury, significant peripheral neuropathy Cognitive disorders, e.g. dementia Interstitial cystitis or chronic pelvic pain syndrome Poorly controlled diabetes mellitus (HbA1c >10%) History of bladder malignancy, pelvic radiation, urinary retention requiring catheterization Anticipated or known need for MRI at the trunk History of or anticipated surgery at the lower back Unable to hold antiplatelet or anticoagulation prior to surgery Life expectancy <1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| overactive bladder patients<br>Female patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation | Device: full stage implantation of sacral neuromodulation<br>* full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in overactive bladder symptoms | measured using overactive bladder questionnaire | 1 year |