Treating Overactive Bladder (OAB) can be a puzzle. After all, we know that more than 80% of patients will discontinue their drugs within the first year due to side-effects, and now there’s compelling evidence that long-term use of anticholinergics increases the risk of dementia and Alzheimer Disease. However, some of the most useful answers to the OAB treatment puzzle come from a well-known study with a different acronym: OrBIT.
The Overactive Bladder Innovative Therapy Trial (OrBIT) studied percutaneous tibial nerve stimulation (PTNS) using the Urgent PC system, alongside the extended release formula of tolterodine tartrate (Detrol® LA). In the study, Urgent PC delivered significant objective improvements, as well as superior subjective improvements compared to the drug.
Examining the Study
The OrBIT Trial was a controlled study of 100 patients conducted by urologists, urogynecologists and nurse practitioners at 11 centers across the United States. The mean age of the subjects was 58 with 30% over 65. More than 90% were female and all suffered from symptoms that included excessive voiding.
Half of the participants received a daily dose of 4 mg tolterodine tartrate extended release. The other half received Urgent PC therapy consisting of 12 weekly, 30-minute sessions of mild electrical stimulation delivered via a needle temporarily placed near the ankle. Voiding diaries and questionnaires were used for baseline analysis, and at the conclusion of the trial.
Highlights from the OrBIT trial include:
- Voiding parameters at 12 weeks, compared to baseline, significantly improved in both groups.
- Subject Global Response Assessment (GRA) was statistically higher for Urgent PC subjects (79.5%) compared to drug subjects (54.8%) with a p value= 0.01.
- Quality of Life indicators changed similarly for both groups.
- Constipation and dry mouth were significantly less frequent in the Urgent PC group.
This study adds to the body of research examining the effectiveness of PTNS therapy with the Urgent PC neuromodulation system. During the past decade, Urgent PC has been used in more than 50 major studies relating to OAB. There have been no serious side-effects related to treatment.
Urgent PC is indicated for the treatment of Overactive Bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence. Treatment with Urgent PC is contraindicated for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function or patients who are pregnant or planning to become pregnant during the duration of the treatment. Most patients don't experience side-effects. If side-effects occur, they are typically temporary and include mild pain and skin inflammation at or near the stimulation site. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For complete instructions for use, storage, warnings, indications, contraindications, precautions, adverse reactions and disclaimer of warranties, please refer to the insert accompanying each product or online at www.cogentixmedical.com. Urgent PC is a registered trademark of Cogentix Medical © 2015 Cogentix Medical. All rights reserved.