Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.
Journal
The American journal of gastroenterology
ISSN: 1572-0241
Titre abrégé: Am J Gastroenterol
Pays: United States
ID NLM: 0421030
Informations de publication
Date de publication:
01 04 2022
01 04 2022
Historique:
received:
01
07
2021
accepted:
19
11
2021
entrez:
31
3
2022
pubmed:
1
4
2022
medline:
2
4
2022
Statut:
ppublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 35354778
doi: 10.14309/ajg.0000000000001605
pii: 00000434-202204000-00026
pmc: PMC8988447
mid: NIHMS1763372
doi:
Banques de données
ClinicalTrials.gov
['NCT03278613']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
654-667Subventions
Organisme : NICHD NIH HHS
ID : U10 HD041261
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD069006
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD069010
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD041267
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD054214
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD041267
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD041261
Pays : United States
Organisme : NICHD NIH HHS
ID : U24 HD069031
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD054241
Pays : United States
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2022 by The American College of Gastroenterology.
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