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. 2012 Dec 12;2012(12):CD001760. doi: 10.1002/14651858.CD001760.pub2

Van Lankveld 2006a.

Methods Design: randomised controlled trial 
 Allocation method: urn randomisation (stratified design) 
 Blinding: assessor blind
Participants Diagnosis: primary vaginismus 
 Criteria: DSM‐IV‐TR 
 Setting: outpatient clinic 
 Number: 117 
 Age: 28.6 years, SD = 6.9 
 Duration of vaginismus: 132 months, SD = 84
Interventions Intervention 1: bibliotherapy + minimal contact (n = 43) 
 Number of sessions: 6 
 Duration of sessions: 15 
 Therapist level: NA 
 Adjunctive interventions: NA
Intervention 2: bibliotherapy + group therapy (n = 38) 
 Number of sessions: 10 
 Duration of sessions: 120 minutes 
 Therapist level: senior therapist 
 Adjunctive interventions: not stated
Intervention 3: waiting list (n = 36) 
 Number of sessions: NA 
 Duration of sessions: NA 
 Therapist level: NA 
 Adjunctive interventions: not stated
Outcomes Successful intercourse 
 Drop‐outs 
 Primary endpoint questionnaire 
 Female Sexual Function Index 
 Maudsley Marital Questionnaire 
 Golombok Rust Inventory of Sexual Satisfaction
Notes Bibliotherapy (manual and CD) comprised sexual education, relaxation exercises, systematic desensitisation, cognitive therapy and sensate focus therapy
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "A person not involved in assessment or treatment delivery performed urn randomization."
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Blinding is not possible for participants or therapists. However, most assessors were blinded to treatment status ‐ "assessment was performed at each research center by two research assistants who were not involved in treatment delivery and who were blinded to the treatment condition of participants, with the exception of one of two assessors in one research center, who was also involved in treatment delivery."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 24 of 117 participants dropped out of treatment. Drop‐outs were roughly equivalent across the 2 active treatment arms of the study (10 and 11 respectively) whilst 3 drop‐outs came from the waiting list control arm.
Investigators used LOCF (last observation carried forward) to impute missing data for drop‐outs.
Selective reporting (reporting bias) Unclear risk Outcome data provided for all stated outcomes but we have no access to study protocols so cannot be certain other outcomes were not assessed
Other bias Low risk None suspected