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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. Neurourol. Urodynam. 31:132–138, 2012. © 2011 Wiley Periodicals, Inc.

Aims To determine the psychometric properties of the (5-item) total PRAFAB-questionnaire score in a group of patients with stress or predominant urgency urinary incontinence (UI) to justify its use in clinical practice and research. Methods Psychometric properties were assessed in a prospective cohort of patients with primary or recurrent UI referred for physiotherapy treatment. Results In total, 99 women enrolled the cohort study, of whom 87 were classified as stable (“about the same” on the global rating scale [GRS]) and included for analyses. Factor analysis resulted in a single underlying factor in both UI groups. The PRAFAB-questionnaire scores demonstrated excellent test–retest reliability (high ICCsagreement [0.93–0.95] and kappa scores for individual items) and excellent internal consistency (Cronbach's alpha's of 0.82). The PRAFAB-questionnaire was able to discriminate among different patient groups indicating good construct validity. Responsiveness to clinical improvement for both groups was shown to be excellent with large effect size statistics and high correlations (0.79–0.89) with patients' perceived benefit on the GRS indicating excellent longitudinal validity. The minimally important change stratified for non-severe and severe classified patients were estimated between −2.5 to −4.6 and −4.5 to −7.0 points, respectively for the stress UI group and −2.5 to −3.4 points and −4.0 to −4.4, respectively for the urgency UI group. Conclusions The brief and simple PRAFAB-questionnaire demonstrated good psychometric properties for use in clinical practice and research to evaluate treatment effects for UI in women. Future research will be necessary to replicate these findings and further explore its psychometric properties. Neurourol. Urodynam. 26:998–1007, 2007. © 2007 Wiley-Liss, Inc.

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.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.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).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.

Aim To determine the psychometric properties of the total Vaizey score and its individual items. Methods The study was conducted as part of a prospective cohort study assessing the outcome of pelvic floor rehabilitation in patients with fecal incontinence. Results One hundred ninety-four patients were analyzed, 53 of whom provided data on the global perceived effect (GPE) score. Pelvic floor rehabilitation resulted in a significant reduction of the total Vaizey score and most individual items. The total Vaizey scores changed in agreement with the GPE scores. The total Vaizey score was responsive, but some individual items yielded inconsistent results for three different measures. The test–retest reliability was adequate or excellent for six individual items and the total Vaizey score. The internal consistency was low for the total Vaizey score at baseline, in contrast to the follow-up and change scores. The estimates for the minimally important change (MIC) and smallest detectable change yielded moderately consistent results. An MIC of −5 points seemed preferable and yielded the lowest misclassification rate. Conclusions More research is required to confirm conclusions on the psychometric properties of the total Vaizey score and its individual items, and to justify its use in research and routine clinical practice. Neurourol. Urodynam. 29:370–377, 2010. © 2009 Wiley-Liss, Inc.