For first-line treatment of patients with fecal incontinence, pelvic floor muscle training (PFMT) is superior to attention-control massage, according to investigators.
Source: American Gastroenterological Association
In a study involving 98 patients, those who combined PFMT with biofeedback and conservative therapy were five times as likely to report improved symptoms than those who used attention-control massage and conservative therapy, reported Anja Ussing, MD, of Copenhagen University Hospital in Hvidovre, Denmark, and colleagues. Patients in the PFMT group also had significantly greater reductions in severity of incontinence, based on Vaizey incontinence score.
“Evidence from randomized controlled trials regarding the effect of PFMT for fecal incontinence is lacking,” the investigators wrote in Clinical Gastroenterology and Hepatology. Although previous trials have evaluated PFMT, none controlled for the effect of interactions with care providers. “To evaluate the effect of PFMT, there is a need for a trial that uses a comparator to control for this nonspecific trial effect associated with the attention given by the health care professional.”
To perform such a trial, the investigators recruited 98 patients with a history of fecal incontinence for at least 6 months. Patients were excluded if they had severe neurologic conditions, pregnancy, diarrhea, rectal prolapse, previous radiotherapy or cancer surgery in the lower abdomen, cognitive impairment, inadequate fluency in Danish, or a history of at least two PFMT training sessions within the past year. Enrolled patients were randomized in a 1:1 ratio to receive PFMT with biofeedback and conservative treatment, or attention-control massage training and conservative therapy. The primary outcome was symptom improvement, determined by the Patient Global Impression of Improvement scale at 16 weeks. Secondary outcome measures included the Fecal Incontinence Severity Index, Vaizey score, and Fecal Incontinence Quality of Life Scale.
Patients were predominantly female, with just three men in the PFMT group and six in the attention-control massage group. The PFMT group also had a slightly higher median age, at 65 years, compared with 58 years in the control group.
At 16 weeks, the difference in self-reported symptoms was dramatic, with 74.5% of patients in the PFMT group reporting improvement, compared with 35.5% in the control group, which translated to an unadjusted odds ratio of 5.16 (P = .0002). When symptom improvements were confined to those who reported being “very much better” or “much better,” the disparity between groups still remained strong, with an unadjusted OR of 2.98 (P = .025). Among the three secondary outcomes, only the Vaizey score showed a significant difference between groups. Patients treated with PFMT had a mean difference in Vaizey score change of –1.83 points, using a scale from 0 to 24, with 24 representing complete incontinence (P = .04).
“We were not able to show any differences between groups in the number of fecal incontinence episodes,” the investigators wrote. “We had much missing data in the bowel diaries and we can only guess what the result would have been if the data had been more complete. Electronic assessment of incontinence episodes could be a way to reduce the amount of missing data in future trials.”
Still, the investigators concluded that PFMT was the superior therapy. “Based on the results, PFMT in combination with conservative treatment should be offered as first-line treatment for adults with fecal incontinence.”
They also highlighted the broad applicability of their findings, regardless of facility type.
“In the current trial, more than one-third of patients had sphincter injuries confirmed at endoanal ultrasound, this reflects the tertiary setting of our trial,” they wrote. “However, our results may be highly relevant in a primary setting because there is an unmet need for treatment of fecal incontinence in primary health care, and the interventions do not necessarily need to be conducted at specialized centers.”
The study was funded by the Danish Foundation for Research in Physiotherapy, The Lundbeck Foundation, the Research Foundation at Copenhagen University Hospital, and the Foundation of Aase and Ejnar Danielsen. The investigators reported additional relationships with Medtronic, Helsefonden, Gynzone, and others.
SOURCE: Ussing A et al. Clin Gastroenterol Hepatol. 2018 Dec 20. doi: 10.1016/j.cgh.2018.12.015.