Abstract

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial

Am J Gastroenterol. 2022 Apr 1;117(4):654-667.doi: 10.14309/ajg.0000000000001605.

 

Halina M Zyczynski 1Holly E Richter 2Vivian W Sung 3Emily S Lukacz 4Lily A Arya 5David D Rahn 6Anthony G Visco 7Donna Mazloomdoost 8Benjamin Carper 9Marie G Gantz 9NICHD Pelvic Floor Disorders Network

 
     

Author information

1Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/ Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.

2Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.

3Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's & Infants Hospital, Providence, Rhode Island, USA.

4Department of Obstetrics, Gynecology & Reproductive Sciences, UC San Diego Health, San Diego, California, USA.

5Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania, USA.

6Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.

7Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina, USA.

8Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA.

9Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, North Carolina, USA.

Abstract

Introduction: To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments.

Methods: Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model.

Results: Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group.

Discussion: Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

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