Is acupuncture a viable alternative to medication for overactive bladder in an elderly female population? This GEMSSTAR (R03) application addresses the goals stated by the NIA to help in the transition of specialists towards aging research. This project will address the priorities stated in three ways: (1) Innovation: This projet will attempt to increase the understanding of how a regimen of acupuncture, a novel intervention, for OAB in elderly women might function in a real world setting. This project will be a feasibility and acceptability study addressing concerns about patient tolerance of a regimen of acupuncture, as well as changes in quality of life and overall patient satisfaction with acupuncture. It is a required starting point needed to design larger trials of acupuncture for OAB in an elderly female population. (2) Significance: This project will lead to larger trials and strog evidence based results of acupuncture's effect on this common, chronic and debilitating problem. (3) Approach: It will enlarge the knowledge base in the field of acupuncture and complementary and alternative medicine (CAM) for a geriatric population with a rigorous study design and appropriate, well characterized and validated measures. The primary hypothesis of this non-inferiority trial is that acupuncture will provide an equal amount of symptom relief for OAB as medical therapy with fewer side effects. This project is the initial stage in testing that hypothesis. In this randomized trial with a secondary one-way crossover, forty women over the age of 65 with OAB will be allocated to either 8 weeks of acupuncture or 8 weeks of medical therapy for OAB. Those in the medical therapy arm will take a standardized dosage of medication daily. After 8 weeks of medication and a 2 week wash out period they will be transitioned to the 8 week acupuncture protocol. Those randomized to the acupuncture protocol will receive an eight week regimen of acupuncture. Every participant will be followed for 8 weeks post-acupuncture intervention. Each participant will complete symptom, side effect and quality of life questionnaires at enrollment and at set times through the intervention and post-intervention phase of the trial. OAB is a chronic and debilitating problem that is present in up to 30 percent of older community dwelling women and more than half of those living in nursing homes. This project will evaluate whether elderly women with OAB are willing to participate and adhere to treatment and data collection while enrolled in a trial comparing medication and acupuncture and provide preliminary data leading to larger multicenter trials in this field.
With this Grant for Early Medical/Surgical Specialists'Transition to Aging Research (GEMSSTAR) (R03) project, the feasibility and acceptability of using a regimen of acupuncture to treat overactive bladder in elderly women will be assessed and the first steps in a non-inferiority trial between acupuncture and medical therapy for this common, chronic and costly problem will be taken. Side effects will be measured in both groups with the goal of identifying a novel therapy for OAB in elderly women that is well tolerated and maintained in this group of women that are most in need of treatment.