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There were two toxic deaths in the MTX → FU and none in the control arm.
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Most of the difference in late morbidity was due to formation of lymphocysts and lymphedema, which occurred in eight cases in the lymphadenectomy group vs none in the control arm.
Pain relief is better and achieved at a faster rate (3/4th of the patients in the intervention arm had pain relief at 15 min versus none in the control arm).
Where reported, vaccination among staff ranged from ≈35%to70%0% in the intervention arm and from none to 32% in the control arm of experimental studies and from 12%to90%0% in observational studies.
The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score.
Cystoscopic complete response was 61% in the MCV arm, and 55% in the control arm.
The response rate was 50% in the intervention arm and 44% in the control arm.
There were 11 dropouts in the art therapy arm and 7 dropouts in the control arm.
Twelve were in the training arm of the trial and 12 were in the control arm.
There was only one grade 4 adverse event (thrombocytopenia) in the RT arm and none in the observation arm.
In the Control arm, minor improvements and deteriorations were observed, none of which were significant.
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