PTNS Safe and Effective for Overactive Bladder
Percutaneous tibial nerve stimulation (PTNS) is safe and effective for treating overactive bladder (OAB) symptoms, a recent study shows.
"This important study is the first publication that demonstrates the effectiveness of PTNS compared to a validated sham procedure," said lead investigator Kenneth M. Peters, MD, Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Mich.
In a randomized study, 220 adult patients with OAB underwent 12 weeks of treatment with PTNS (using the Urgent PC system, Uroplasty, Inc.) or a sham procedure. Subject global response assessments for overall bladder symptoms at 13 weeks showed that 54.5% of PSNS-treated patients reported symptoms as moderately or markedly improved from baseline compared with 20.9% of sham subjects, according to findings published in The Journal of Urology (2010;183:1438-1443).
In addition, mean voiding frequency (the average number of intentional voids per day (day and night in a three-day voiding diary) decreased from 12.3 at baseline to 9.8 at 13 weeks in the PTNS group and from 12.4 to 11 in the sham group. The decline in frequency was significantly greater in the PTNS group. The mean number of nighttime voids also decreased significantly more in the PTNS group (from 2.9 to 2.1 in the PTNS group and from 2.9 to 2.6 in the sham group).
PTNS was associated with significantly greater improvements in moderate to severe urgency as measured by the median number of voids per day (in a three-day diary). Moderate to severe urgency declined from 8.3 at baseline to 3.7 at 13 weeks in PTNS group and from 8.0 to 5.0 in the sham group. Urge incontinence, as measured by the median number of incontinence episodes accompanied by moderate to severe urgency per day (day and night in a three-day voiding diary), also decreased significantly more in the PTNS than the sham group. It decreased from 3.0 to 0.3 in the PTNS patients and from 1.8 to 1.0 in the sham group.
"The results of this study provide strong scientific evidence that the therapeutic effect of PTNS is due to the stimulation of the posterior tibial nerve and is not due to a placebo effect," the authors wrote.
They also observed: "The compelling efficacy of the PTNS as demonstrated in this trial, along with other recently published reports, should have a significant impact on the future clinical management of OAB."
Dr. Peters and his team stated that PTNS is an "excellent option" for patients who are unwilling or unable to tolerate systemic antimuscarinic adverse events (including dry mouth, constipation, and central nervous system effects), patients with conditions refractory to medical and behavioral treatments, and individuals who do not want to have or are not candidates for an implantable surgical device or reconstructive surgery. n