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Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction [with consumer summary]
Dorey G, Speakman M, Feneley R, Swinkels A, Dunn C, Ewings P
British Journal of General Practice 2004 Nov;54(508):819-825
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The pelvic floor muscles are active in normal erectile function. Therefore, it was hypothesised that weak pelvic floor muscles could be a cause of erectile dysfunction. AIMS: To compare the efficacy of pelvic floor muscle exercises and manometric biofeedback with lifestyle changes for men with erectile dysfunction. DESIGN OF STUDY: Randomised controlled trial. SETTING: The Somerset Nuffield Hospital, Taunton, United Kingdom. METHOD: Fifty-five men with erectile dysfunction (median age 59.2 years; range 22 to 78 years) were enrolled from a local urology clinic of these, 28 participants were randomised to an intervention group and engaged in pelvic floor exercises, as well as receiving biofeedback and suggestions for lifestyle changes. Twenty-seven controls were solely advised on lifestyle changes Baseline, 3- and 6-month assessments were: erectile function domain of International Index of Erectile Function (IIEF), Partner's International Index of Erectile Function (PIIEF), Erectile Dysfunction-Effect on Quality of Life (ED-EQoL), anal manometry, digital anal measurements, and clinical assessment by an assessor blind to treatment allocation. After 3 months, the control group were transferred to the active arm. RESULTS: At 3 months, compared with controls, men in the intervention group showed significant mean increases in the erectile function domain of the IIEF (6.74 points, p = 0.004); anal pressure (44.16 cmH2O, p < 0.001); and digital anal grades (1.5 grades, p < 0.001). All showed further improvement in these outcomes at 6 months similar benefits were seen in men of the control arm after transfer to active treatment. A total of 22 (40.0%) participants attained normal function, 19 (34.5%) participants had improved erectile function, and 14 (25.5%) participants failed to improve. CONCLUSION: Pelvic floor muscle exercises and biofeedback are an effective treatment for men with erectile dysfunction.

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