Methods |
Design: three group parallel trial
Purpose: examine the effect of pelvic floor exercises on orgasmic potential |
Participants |
Patients: female out‐patients not having had an orgasm for two years
Baseline comparability: NS |
Interventions |
Placebo: instruction to do relaxation exercises
Untreated: no exercises (waiting‐list)
Experimental: instructions to do pelvic floor exercises
(Co‐intervention: no psychological counselling) |
Outcomes |
Number of women having had orgasm |
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/exercise instructions) |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
Trial size > 49? |
High risk |
N = 26 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |