BERKELEY, CA (UroToday.com) - Overactive bladder (OAB) is a chronic condition significantly affecting the lives of 34 million U.S. adults.
Like other chronic conditions, OAB requires lifelong therapy, which may present a challenge to patients who are unresponsive to behavioral interventions, unable to tolerate medication, or who wish to avoid surgery. Percutaneous tibial nerve stimulation (PTNS), using the Urgent® PC Neuromodulation System, offers patients an effective and well-tolerated treatment option for long-term OAB therapy.
|To learn more about percutaneous tibial nerve stimulation, visit www.ptnsinfo.com|
OAB is a multifaceted syndrome with individual variation in symptoms and response to treatment. Behavioral interventions, pharmacotherapy, and neuromodulation therapy using PTNS or implantable sacral nerve stimulation (SNS) all require continuous treatment to sustain OAB symptom improvement. Although pharmacotherapy effectively reduces OAB symptoms, more than 70% of patients discontinue these drugs within one year due to intolerable side effects or insufficient improvement in symptoms. SNS is also an effective treatment for OAB but its use may be limited due to associated costs, surgical implantation, and potential for surgical revision.
PTNS is an easily administered, office-based procedure designed to deliver retrograde neuromodulation to the sacral nerve plexus, through the tibial nerve, via temporary insertion of a 34-gauge needle electrode near the ankle. An advantage of PTNS is that it does not require surgical implantation of a power supply, leads or electrodes, or the use of prophylactic antibiotics. PTNS therapy is initiated with 12 weekly 30-minute treatments. Results from the SUmiT (Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms) Trial found significant improvement in OAB symptoms from the 6th to the 12th PTNS treatment. This data demonstrates 12 weekly PTNS treatments are needed to realize the full treatment effect for those suffering with OAB. Following the initial 12 weekly treatments, responders are advised to continue therapy to sustain their OAB symptom improvement with approximately one treatment per month.
Recent results from the Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation (STEP) Study reported sustained efficacy of PTNS therapy through 36 months with a median of 1.1 treatments a month following initial success at 12 weeks. Of the 52 subjects enrolled, 29 completed their 36-month visit. Voiding diary parameters at 6, 12, 18, 24 and 36 months were significant for improvement compared to baseline for frequency (12.0 to 8.7 per day), incontinence episodes (3.7 to 0.3 per day), nighttime voids (2.7 to 1.7 per night), and moderate to severe urgency episodes (8.5 to 3.5 per day) (all p < 0.0001). OAB-q symptom severity scores and health-related QoL scores were also statistically significant for improvement at each tested time point compared to baseline. During the STEP Study, two mild treatment-related adverse events of bleeding at the needle site were reported in the same participant. One moderate and 11 mild adverse events, not related to treatment, were reported in nine patients.
In addition to being an effective and safe treatment for OAB, PTNS is also a cost-effective way to deliver neuromodulation treatment to patients. Compared to SNS, botulinum toxin A, and augmentation cytoplasty, PTNS was reported to be the least costly and compared favorably to pharmacotherapy. Furthermore, Martison, et al. reported the cumulative 3-year costs for patients who remain on one of the following therapies to be $7,565 for PTNS, $11,748 for botulinum toxin A, $16,830 for augmentation cystoplasty, and $24,681 for SNS.
The therapeutic goal for treating OAB is to restore the patient’s quality of life to a level that is defined by the patient and relevant to their activities of daily living, while balancing efficacy and side effects. The sustainability of OAB symptom improvement with PTNS therapy has been demonstrated in 3 durability studies of 12-36 months in length with no major safety concerns.[4, 7, 8] In addition, over 30 peer-reviewed publications have shown high efficacy rates with Urgent PC making PTNS an excellent long-term treatment option for patients with OAB.
Urgent PC is an essential part of a comprehensive OAB treatment program. It can be incorporated into any practice that delivers a complete spectrum of urologic care. After specific training, it can be administered by staff who can encourage patients to attend treatment sessions, reinforce behavioral changes, and track patient progress. Normal exam rooms can be used for therapy or even those rooms in your practice that may not be fully utilized, like conference rooms.
- Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World Journal of Urology 2003; 20(6): 327-36.
- Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A medium-term analysis of the subjective efficacy of treatment for women with detrusor instability and low bladder compliance. Br J Obstet Gynaecol 1997; 104(9): 988-93.
- Peters KM CD, Miller CJ. Clinical insights into percutaneous tibial nerve stimulation for the threatment of overactive bladder syndrome: secondary analysis of the SUmiT Trial. Western Section of the American Urological Association (WSAUA); 2012; Waikoloa Village, Hawaii; Abstract.
- Peters KM CD, Wooldridge LS, Miller CJ, MacDiarmid SA. Percutaneous tibial nerve stimulation (PTNS) the long-term treatment of overactive bladder: three-year results of the STEP study J Urol 2013.
- Staskin DR, Peters KM, Macdiarmid S, Shore N, de Groat WC. Percutaneous Tibial Nerve Stimulation: A Clinically and Cost Effective Addition to the Overactive Bladder Algorithm of Care. Current Urology Reports 2012.
- Martinson M, Macdiarmid S, Black E. Cost of Neuromodulation Therapies for Overactive Bladder: Percutaneous Tibial Nerve Stimulation Versus Sacral Nerve Stimulation. J Urol 2012.
- MacDiarmid S, Peters K, Leong F, et al. Long-term sustained therapeutic effect of percutaneous tibial nerve stimulation in the management of overactive bladder. AUA Annual Meeting. Chicago, USA: J Urol 181: 4, Supplement; 2009. p. 677-8.
- Yoong W, Shah P, Dadswell R, Green L. Sustained effectiveness of percutaneous tibial nerve stimulation for overactive bladder syndrome: 2-year follow-up of positive responders. Int Urogynecol J 2012.
Kenneth M. Peters, MD as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.
Beaumont Hospital, Royal Oak, MI USA