Baldoni 1995.
Methods | Single‐centre RCT, 2‐year study, parallel design | |
Participants | 36 women with urethral syndrome (urinary symptoms and pain without organic lesions) aged 18‐63 years (mean 40). All complained of urgency, dysuria and tenesmus at the first evaluation | |
Interventions | Intervention: STDP (Davanloo 1980; Malan 1979). The psychotherapy consisted of 12‐16 weekly sessions lasting 1 hr conducted by a single psychotherapist Control: "traditional urological treatment", which included medical therapy (anticholinergic and alpha‐adrenoceptor antagonist drugs) and urethral dilation Both groups had 3‐4 months of therapy for a mean of 14 weeks |
|
Outcomes | Pre‐, 6 months post‐, 4 years post‐treatment. Presence and nature of urinary disorders such as urgency, dysuria, tenesmus; number of day and night micturitions; pain in the pelvic area and its features; the Symptom Questionnaire, which can discriminate between psychiatric patients and others and between various psychological discomfort levels by assessing anxiety, depression, somatic symptoms and hostility. Continuous data from Symptom Questionnaire used as obtained from authors | |
Notes | 4 participants allocated to STDP group were given antidepressant pharmacotherapy (a combination of amitriptyline and mianserin) but 2 stopped treatment before completion and are not considered in the results Data obtained from authors in form of means, standard deviations for outcomes of interest: anxiety, depression and somatic symptoms of Symptom Questionnaire | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "randomly selected on the basis of the psychotherapist's schedule. i.e. when a treatment could be started, the urologists were asked to send the first patient" Comment: sequence generated by a non‐random approach |
Allocation concealment (selection bias) | High risk | Comment: not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: self report questionnaires only: low risk Blinding participants to treatment group not possible No psychotherapist was blinded to the treatment delivered |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: did not include drop‐outs in analysis but reported on clinical status |
Selective reporting (reporting bias) | High risk | Comment: did not include complete outcome data on all measures for entry in a meta‐analysis |
Other bias | Unclear risk | Comment: insufficient information to permit judgement |