| Methods |
Design: five group parallel trial
Purpose: study the effect of three different psychological interventions on secondary erectile dysfunction |
| Participants |
Patients: men with secondary erectile dysfunction
Baseline comparability: yes |
| Interventions |
Placebo: sessions with factual information on sexual education and relationship enhancement
Untreated: no sessions
Experimental:
‐sessions with communication technique training
‐sessions with sexual technique training
‐sessions with combination treatment
(Co‐intervention: NS) |
| Outcomes |
Coital success in %
Marital adjustment test
Sexual interaction inventory
Sexual anxiety inventory
Sexual pleasure rating |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/psychological interventions) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
High risk |
N = 8 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
