LUGPA 2016: Care Pathways and Advanced Therapies in the Treatment of OAB

Chicago, Illinois ( Clinical care pathways for overactive bladder treatment have the potential to transform the management of this urinary condition by improving patient care and practice efficiency, according to speakers at a Continuing Medical Education (CME) session at the 2016 annual meeting of the Large Urology Group Practice Association (LUGPA) in Chicago.

 “Many women with overactive bladder show poor compliance with medications, and one new approach to improving adherence is to use research-based clinical care pathways,” said co- chair David C. Chaikin, MD, urologist at the Garden State Urology in New Jersey, at the CME session, “Optimizing Bladder Disease Management.” Clinical care pathways not only improve treatment options for women with OAB, but also have the potential to increase practice efficiency by ensuring that patients obtain cost-effective treatment, according to Dr. Chaikin.

Yet clinical care pathways need physician champions within a practice to work, as well as a commitment to improving pelvic health within a practice.  “With clinical care pathways for OAB, a practice can enhance its reputation as well as preventing the loss of patients to other physicians and practices,” Dr. Chaikin said.

 Clinical care pathways for OAB establish standardized algorithms for treatments, and are supported by scientific evidence, said Eric Rovner, MD, Professor in the Department of Urology at the Medical University of South Carolina in Charleston. Dr. Rovner is also the director of the Section of Voiding Dysfunction, Female Urology and Urodynamics in the Department of Urology at MUSC. For patients, the variety of treatment options included in a clinical care pathway keeps them engaged in their treatment. For the referring physician, a clinical care pathway provides a proven approach to OAB treatment, outlines when it is time to refer to a specialist and satisfies Physician Quality Reporting System (PQRS) requirements. 

Treating physicians also benefit from an OAB clinical care pathway, since it establishes a consistent care process and patient education tools, and satisfies PQRS requirements. Finally, a clinical care pathway can streamline insurance coverage approvals from payers, since these pathways demonstrate that OAB patients are receiving consistent high quality care, Dr. Rovner said. 

One of the most important reasons to institute an OAB clinical care pathway is the need to improve patient adherence to their therapies. Studies in the U.S. and Europe have found that less than 30% of patients are adherent to OAB medications at 6 months, and the median time for discontinuation is just 4.5 months. Also, less than 5% of OAB patients move on to advanced therapies such as Botox, sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS).1-3

Yet, a clinical care pathway provides an evidence-based approach that helps standardize initial behavioral therapies and medications, sets out a reasonable duration for each treatment trial, and provides a means for moving patients seamlessly to advanced therapies. As well as increasing awareness of OAB among patients and primary care providers, a clinical care pathway can facilitate pre-approval for different tiers of care and enhance pay for performance from payers, Dr. Rovner said. 

The Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) has designed a new clinical care pathway and Web site, for instance, that offers educational materials for specialists and primary care providers, an OAB clinical care pathway registry, and standardized patient education materials about different therapies. The SUFU Web site, now in development, also includes a flow diagram or “road map” for patients that sets out the expected times and possible outcomes for each sequential therapy. “The material provides primary care doctors with a means for defining the best ways to approach overactive bladder, as well as giving patients detailed information and tools, such as a void diary,” Dr. Rovner said. “Eventually all this material will also be available as a smart phone app.”

Clinical care pathways can steer patients toward the most effective advanced therapies and emerging new technologies for OAB, and give guidance on how to counsel patients about individualized treatment choices. The only randomized clinical trial of advanced OAB treatments, the ROSETTA trial, published in JAMA in 20164--also provided some new clues and insights into the benefits and risks of different advanced OAB treatments. The trial of 2200 OAB patients—all of whom had failed two drugs—found that symptom control was better with Botox than with neuromodulation. However, urinary tract infections and the need for transient self-catherization was also greater with Botox injections than with neuromodulation, Dr. Rovner said. 

 “Botox did marginally better than neuromodulation in this population, but from a clinical perspective, both treatments worked very well,” he said. “I usually counsel patients against Botox if they have risk factors for urinary tract infections or intermittent catherization, or if they fear or are uncomfortable with repeat injections,” Dr. Rovner added. “By contrast, patients who are anesthesia risks or have compromised cognitive function should not receive neuromodulation.”

In the future, administration of Botox may be made easier by emerging technologies that deliver the drug via nanocarriers, such as liposomes, with ultrasound or via a gel that is absorbed across the urothelium. Treatment options for OAB may also be enhanced by new medications for OAB, such as abotulinumtoxinA or Dysport, currently in phase III trials. Other technologies now in development for OAB treatment include MRI-compatible and rechargeable SNS implants and small rechargeable sacral neuromodulation (SNM) implants.  “On the PTNS front, the next advances we will see will be implantable devices. Four companies have implantable devices in development, and these devices will most likely be part of the next wave of OAB therapy,” Dr. Rovner said. 

 Presented by: David C. Chaikin and Eric Rovner

  1. Wagg A, Compion G, Fahey A, et al. Persistence with prescribed antimuscarinic therapy for overactive bladder: A UK experience. BJU Int. 2012; 110 (11): 1767-74. 

  2. Shaya FT, Blume S, Gu A, et al. Persistence with overactive bladder pharmacotherapy in a Medicaid population. Am J Manag Care. 2005; 11 (4 Suppl): S121-9. 

  3. Gopal M, Haynes K, Bellamy SL, et al. Discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms. Obstet Gynecol. 2008; 112 (6): 1311-8.

  4. Amundsen CL, Richter HE, Menefee SA, et al. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: A randomized clinical trial. JAMA 2016; 316 (13): 1366-1374.