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.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: December 2022
- Device: full stage implantation of sacral neuromodulation
- full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence
Arms, Groups and Cohorts
- overactive bladder patients
- Female patients with refractory overactive bladder and urge urinary incontinence undergoing direct full stage implantation
Clinical Trial Outcome Measures
- Improvement in overactive bladder symptoms
- Time Frame: 1 year
- measured using overactive bladder questionnaire
Participating in This Clinical Trial
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 100 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Loma Linda University
- Provider of Information About this Clinical Study
- Principal Investigator: Andrea Staack, MD PhD – Loma Linda University
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