AIMS: Fecal incontinence (FI) is embarrassing, resulting in poor quality of life. Rectal sensation may be more important than sphincter strength to relieve symptoms. A single-blind, randomized controlled trial among adults with FI compared the effectiveness of rectal balloon training (RBT) and pelvic floor muscle training (PFMT) versus PFMT alone. METHODS: We randomized 80 patients, recruited from the Maastricht University Medical Centre. Primary outcome was based on the Vaizey score. Secondary outcomes were the Fecal Incontinence Quality of Life Scale (FIQL), 9-point global perceived effect (GPE) score, anorectal manometry, rectal distension volumes, and thresholds of anorectal sensation. Analyses were by intention-to-treat. RESULTS:Forty patients were assigned to combined RBT with PFMT and 40 to PFMT alone. Adding RBT did not result in a significant improvement in the Vaizey score [mean difference: -1.19; 95% confidence interval (CI): -3.79 to 1.42; P = 0.37]. Secondary outcomes favoring RBT were: Lifestyle subscale of the FIQL (0.37; 95% CI: 0.02-0.73; P = 0.04), GPE (-1.01; 95% CI: -1.75 to -0.27; P = 0.008), maximum tolerable volume (49.35; 95% CI: 13.26-85.44; P = 0.009), and external anal sphincter fatigue (0.65; 95% CI: 0.26-1.04; P = 0.001). Overall, 50% of patients were considered improved according to the estimated minimally important change (Vaizey change ≥-5). CONCLUSIONS:RBT with PFMT was equally effective as PFMT alone. Secondary outcomes show beneficial effects of RBT on urgency control, GPE, and lifestyle adaptations. Characteristics of patients who benefit most from RBT remain to be confirmed.
RCT Entities:
AIMS: Fecal incontinence (FI) is embarrassing, resulting in poor quality of life. Rectal sensation may be more important than sphincter strength to relieve symptoms. A single-blind, randomized controlled trial among adults with FI compared the effectiveness of rectal balloon training (RBT) and pelvic floor muscle training (PFMT) versus PFMT alone. METHODS: We randomized 80 patients, recruited from the Maastricht University Medical Centre. Primary outcome was based on the Vaizey score. Secondary outcomes were the Fecal Incontinence Quality of Life Scale (FIQL), 9-point global perceived effect (GPE) score, anorectal manometry, rectal distension volumes, and thresholds of anorectal sensation. Analyses were by intention-to-treat. RESULTS: Forty patients were assigned to combined RBT with PFMT and 40 to PFMT alone. Adding RBT did not result in a significant improvement in the Vaizey score [mean difference: -1.19; 95% confidence interval (CI): -3.79 to 1.42; P = 0.37]. Secondary outcomes favoring RBT were: Lifestyle subscale of the FIQL (0.37; 95% CI: 0.02-0.73; P = 0.04), GPE (-1.01; 95% CI: -1.75 to -0.27; P = 0.008), maximum tolerable volume (49.35; 95% CI: 13.26-85.44; P = 0.009), and external anal sphincter fatigue (0.65; 95% CI: 0.26-1.04; P = 0.001). Overall, 50% of patients were considered improved according to the estimated minimally important change (Vaizey change ≥-5). CONCLUSIONS: RBT with PFMT was equally effective as PFMT alone. Secondary outcomes show beneficial effects of RBT on urgency control, GPE, and lifestyle adaptations. Characteristics of patients who benefit most from RBT remain to be confirmed.
Authors: J Eric Jelovsek; Alayne D Markland; William E Whitehead; Matthew D Barber; Diane K Newman; Rebecca G Rogers; Keisha Dyer; Anthony Visco; Vivian W Sung; Gary Sutkin; Susan F Meikle; Marie G Gantz Journal: Contemp Clin Trials Date: 2015-08-18 Impact factor: 2.226
Authors: Alayne D Markland; J Eric Jelovsek; David D Rahn; Lu Wang; Leah Merrin; Ashok Tuteja; Holly E Richter; Susan Meikle Journal: Female Pelvic Med Reconstr Surg Date: 2017 May/Jun Impact factor: 2.091
Authors: A D Markland; J E Jelovsek; W E Whitehead; D K Newman; U U Andy; K Dyer; I Harm-Ernandes; S Cichowski; J McCormick; C Rardin; G Sutkin; A Shaffer; S Meikle Journal: Neurogastroenterol Motil Date: 2016-07-24 Impact factor: 3.598