SAN FRANCISCO—Patients with overactive bladder (OAB) who respond well to 12 weeks therapy with a percutaneous tibial nerve stimulation (PTNS) device are likely to have sustained improvement at 12 months, investigators announced at the 39th Annual Meeting of the International Continence Society.

Neuromodulation therapy uses electrical stimulation to target specific nerves in the sacral plexus that control bladder function. Percutaneous tibial nerve stimulation targets the sacral plexus from the posterior tibial nerve. The treatment is intended for use in the physician’s office.

“Neuromodulation therapy like PTNS is minimally invasive and provides sustained improvements with a high rate of patient satisfaction and thus should be offered early in the course of OAB treatment rather than uniformly viewed as a treatment of last resort,” said Kenneth Peters, MD, Chairman of the Department of Urology at William Beaumont Hospital in Royal Oak, Mich.

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It remains unclear which patients are likely to respond best to neuromodulation, he noted.  “We don’t have the data yet,” he said. “But, in my opinion, older patients don’t respond as well as younger patients, and that’s why I don’t think we should wait until the bitter end to treat patients using this approach.”

Dr. Peters reported the results of an extension phase of the Overactive Bladder Innovative Therapy (OrBIT) trial, which compared the effectiveness of once-weekly PTNS to standard drug treatment using 4 mg daily extended-release tolterodine. An analysis at 12 weeks showed equal objective improvement in OAB symptoms between the drug and PTNS, whereas patients receiving PTNS reported significant subjective improvements compared with drug therapy. 

Overall, 35 patients who had an improvement in their OAB symptoms after 12 weekly sessions of PTNS therapy were offered on-going PTNS therapy for 12 months. Therapy was provided at treatment intervals that were tapered to maintain symptom relief for the individual patient.

Results at 12 months showed sustained significant improvements in several objective urinary parameters based on patients’ voiding diaries. Notably, 24-hour voiding frequency was reduced by a mean of 2.8 voids per day, urge urinary incontinence episodes by a mean of 1.6 episodes per day, and nighttime voids causing nighttime awakening by a mean of 0.8 voids. The amount of voided volume increased by a mean of 39 cc.

Additionally, PTNS produced prolonged quality of life improvements as assessed by both patients and investigators. The investigators observed no serious adverse effects or device malfunctions.

Dr. Peters pointed out that he usually recommends neuromodulatory therapy once the patient has failed a maximum of two medications. “If patients don’t improve after two drugs, additional drugs aren’t likely to work either,” he related.

He said he believes that the sole limitation of PTNS treatment is the time commitment.  “Patients need to come to the office to be treated once a week for 12 weeks, and this would be followed by once monthly maintenance therapy,” he said.

He added, however, that the time commitment pays off. “In our trial, the majority of patients who did well at 12 weeks did well at 12 months, and that says a lot.”