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Sexual rehabilitation for cardiac patients with erectile dysfunction: a randomised clinical trial [with consumer summary]
Palm P, Zwisler AO, Svendsen JH, Thygesen LC, Giraldi A, Jensen KG, Lindschou J, Winkel P, Gluud C, Steinke E, Berg SK
Heart 2019 May;105(10):775-782
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; 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: Sexual dysfunction is common in patients with either ischaemic heart disease (IHD) or implantable cardioverter defibrillator (ICD) and has a negative impact on quality of life. Non-pharmacological treatment options are lacking. The purpose of this trial was to assess the effect of sexual rehabilitation versus usual care for males with erectile dysfunction and either IHD and/or ICD. METHODS: Participants with erectile dysfunction and IHD and/or ICD were randomised to 12 weeks of sexual rehabilitation consisting of physical exercise training, pelvic floor exercise and psychoeducation, or usual care. PRIMARY OUTCOME: Sexual function by the International Index of Erectile Function (IIEF). Secondary outcome: sexual function by the Psychosocial Adjustment to Illness Scale. Exploratory outcomes: exercise capacity, pelvic floor strength/endurance, self-reported health and mental health. RESULTS: 154 participants were included, mean age 61.6 years (SD 6.1). Sexual rehabilitation compared with usual care improved sexual function with a mean difference IIEF score of 6.7 (95% CI 3.1 to 10.4, p < 0.0003) at 4 months between groups (unadjusted IIEF mean scores 36.4 versus 31.3) and a mean difference of 6.7, 95% CI 3.2 to 10.1 (p < 0.0002) at 6 months between groups (unadjusted mean scores IIEF 37.1 versus 32.2). No effects were seen on the secondary outcome. Sexual rehabilitation improved exercise capacity on cycle ergometer measured by Watt max with a mean difference of 10.3, 95% CI 3.6 to 16.9 (p < 0.003) and pelvic floor strength (p < 0.01). No differences were seen on self-reported health and mental health. CONCLUSION: Sexual rehabilitation compared with usual care improves sexual function and exercise capacity. TRIAL REGISTRATION: NCT01796353; results.
Reproduced with permission from the BMJ Publishing Group.

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