BACKGROUND: Stress urinary incontinence, fecal incontinence, and pelvic organ prolapse are common forms of pelvic floor dysfunction. Pelvic floor muscle training is used to improve pelvic floor function, through a program of exercises. We conducted a health technology assessment of pelvic floor muscle training for people with stress urinary incontinence, fecal incontinence, or pelvic organ prolapse, which included an evaluation of effectiveness, safety, and the budget impact of publicly funding pelvic floor muscle training, and patient preferences and values.
METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of included studies using the ROBIS tool, for systematic reviews, and the Cochrane Risk of Bias tool, for randomized controlled trials, and we assessed the quality of the body of evidence according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search but did not conduct a primary economic evaluation. We also analyzed the budget impact of publicly funding pelvic floor muscle training in adults with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse in Ontario. To contextualize the potential value of pelvic floor muscle training as a treatment, we spoke with people with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse.
RESULTS: We included 6 studies (4 systematic reviews and 2 randomized controlled trials) in the clinical evidence review. In comparison with no treatment, pelvic floor muscle training significantly improved symptom severity and increased patient satisfaction in women with stress urinary incontinence or pelvic organ prolapse (GRADE: Moderate). For men with stress urinary incontinence after prostatectomy, pelvic floor muscle training yielded mixed results for symptom improvement (GRADE: Very low). For adults with fecal incontinence, pelvic floor muscle training did not improve symptoms in comparison with standard care (GRADE: Very low).In the economic literature review, we included 6 cost-utility analyses that had evaluated the cost-effectiveness of pelvic floor muscle training as a treatment for people with pelvic organ prolapse or urinary incontinence. We did not identify any economic studies on pelvic floor muscle training for women or men with fecal incontinence or men with pelvic organ prolapse. The analyses included in our review found that, for women with stress urinary incontinence, pelvic floor muscle training was likely cost-effective in comparison with other nonsurgical interventions. For men with urinary incontinence after prostate surgery, pelvic floor muscle training was likely not cost-effective in comparison with standard care. For women with pelvic organ prolapse, the cost-effectiveness of pelvic floor muscle training in comparison with no active treatment was uncertain.The average cost of pelvic floor muscle training was approximately $763 per patient. Publicly funding pelvic floor muscle training for women with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse would result in additional costs over 5 years of $185.3 million, $275.6 million, and $85.8 million, respectively. Publicly funding pelvic floor muscle training for men with stress urinary incontinence and fecal incontinence would result in additional costs over 5 years of $10.8 million and $131.1 million, respectively. The people we spoke with reported that stress urinary incontinence, fecal incontinence, and pelvic organ prolapse limited their social and physical activities, taking a huge emotional toll. Many were hesitant or even fearful of surgery, and most people with experience of pelvic floor muscle training reported that it relieved most or all of their symptoms and allowed them to return to normal daily activities.
CONCLUSIONS: Pelvic floor muscle training is likely more effective (with respect to symptom improvement and patient satisfaction) than no treatment for women with stress urinary incontinence or pelvic organ prolapse. Pelvic floor muscle training may yield mixed results with respect to symptom improvement for men with stress urinary incontinence after prostatectomy and have little to no effect on symptom improvement for adults with fecal incontinence. We estimate that publicly funding pelvic floor muscle training for adults with pelvic floor dysfunction (stress urinary incontinence, fecal incontinence, and pelvic organ prolapse) in Ontario would result in a substantial budget increase over the next 5 years. People with stress urinary incontinence, fecal incontinence, and pelvic organ prolapse shared the negative impact these conditions have on their social and physical life and valued pelvic floor muscle training as a nonsurgical treatment option.