INTRODUCTION: Urinary incontinence (UI) is a significant health problem with considerable social and economic impact. It is a distressing condition which has a profound effect on quality of life. A common cause of urge incontinence is inappropriate bladder contractions. Abnormal nerve signals might be the cause of these bladder spasms.Therapy using percutaneous tibial nerve stimulation (PTNS) has been shown effective in the treatment of overactive bladder symptoms. This sub-analysis specifically identifies subjects with UI to evaluate their reduction in symptoms after 12 weeks of treatment.
METHODS: 220 subjects were randomized 1:1 to PTNS or validated sham as part of their participation in the SUmiT Trial, a multicenter IRB-approved trial. Subjects received 12 PTNS or sham treatments during 30-minute weekly sessions. Subjects completed questionnaires and 3-day voiding diaries during their participation. PTNS was percutaneously delivered through a 34-gauge needle electrode inserted near the posterior tibial nerve using the Urgent PC device for 12 weekly 30-minute sessions. A surface electrode and 2 sham electrode pads were placed for consistency with the sham. The sham used a Streitberger placebo needle providing the sensation of a needle, but without piercing the skin. TENS electrode pads placed above and below the small toe provided the sensation of stimulation without tibial nerve activation, and an inactive surface electrode was placed as in PTNS. The audible PTNS device sounds were also reproduced in the sham intervention to diminish auditory variation between groups. Of these 220 subjects, 164 subjects experienced urge incontinence at baseline; 80 PTNS and 84 sham subjects. All subjects completed 3-day voiding diaries and questionnaires during their participation.
RESULTS OBTAINED: After 12 treatments, subjects randomized to PTNS had a greater percent reduction in UI compared to sham. See table. Additionally, Global Response Assessment (GRA) in this selected population demonstrates PTNS is statistically significant for improvement in overall bladder symptoms, frequency, urgency, and urinary urge incontinence. See graph.
|
Proportion of subjects |
Percent reduction in UI after 12 treatments |
|||
|
25% |
50% |
75% |
100% |
|
|
PTNS |
79% |
65% |
46% |
29% |
|
Sham |
57% |
49% |
31% |
19% |
CONCLUSION: PTNS therapy is effective in reducing urge incontinence.
Source: Original poster
