Urge Incontinence, Urinary Bladder, Overactive
Conditions
Brief summary
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.
Interventions
DEVICEfull stage implantation of sacral neuromodulation
full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence
Sponsors
Loma Linda University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in overactive bladder symptoms | 1 year | measured using overactive bladder questionnaire |
Countries
United States
Outcome results
None listed