| Popis: |
OBJECTIVE: To determine whether PTNS is superior to sham stimulation for treatment of fecal incontinence in women refractory to first-line treatments. METHODS: Women ≥18 years with ≥3 months of moderate to severe fecal incontinence that persisted after a 4-week run-in were randomized 2:1 (PTNS:Sham) to 12-weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline fecal incontinence severity measured by St Mark’s score after 12 weeks treatment (range 0–24; minimal important difference, 3–5 points). Secondary outcomes included electronic bowel diary events and quality of life. Groups were compared using an adjusted general linear mixed model. RESULTS: Of 199 women entering run-in, 166 (of 170 eligible) were randomized, (111 PTNS, 55 sham); mean (SD) age, 63.6 (11.6) years; baseline St. Mark’s score, 17.4 (2.7); recording 6.6 (5.5) fecal incontinence episodes per week. There was no difference in improvement from baseline St. Mark’s scores in the PTNS group compared to the sham group (−5.3 vs. −3.9 points, adjusted difference [95% confidence interval] −1.3 [−2.8, 0.2]). Groups did not differ in reduction in weekly fecal incontinence episodes (−2.1 vs. −1.9 episodes, adjusted difference [95% confidence interval] −0.26 [−1.85, 1.33]). Condition-specific QOL measures did not indicate a benefit of PTNS over sham. Serious adverse events occurred in 4% of each group. CONCLUSIONS: Though symptom reduction after 12 weeks of PTNS met a threshold of clinical importance it did not differ from sham. These data do not support use of PTNS as conducted, for treatment of fecal incontinence in women. |
