Linda Brubaker led the review process.
Original Clinical Article
Article first published online: 28 OCT 2011
Copyright © 2011 Wiley Periodicals, Inc.
Neurourology and Urodynamics
Volume 31, Issue 1, pages 132–138, January 2012
How to Cite
Bols, E., Berghmans, B., de Bie, R., Govaert, B., van Wunnik, B., Heymans, M., Hendriks, E. and Baeten, C. (2012), Rectal balloon training as add-on therapy to pelvic floor muscle training in adults with fecal incontinence: A randomized controlled trial. Neurourol. Urodyn., 31: 132–138. doi: 10.1002/nau.21218
Conflict of interest: none.
The study sponsor had no role in the study design, in the collection, analysis and interpretation data, in the writing of the report, and in the decision to submit the paper for publication.
- Issue published online: 23 JAN 2012
- Article first published online: 28 OCT 2011
- Manuscript Accepted: 16 AUG 2011
- Manuscript Received: 13 MAY 2011
- Medeco BV
- fecal incontinence;
- pelvic floor;
- physical therapy;
- Vaizey score
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. Neurourol. Urodynam. 31:132–138, 2012. © 2011 Wiley Periodicals, Inc.