Holger Thiele.

Methods Research Oversight The IABP-SHOCK II trial was a multicenter, open-label, randomized study. The design of the trial offers been published previously.11 The trial was designed by the first author and modified by the steering committee ; the trial style was authorized by the ethics committee at each participating middle. Neither Maquet Cardiopulmonary nor Teleflex Medical, both of which supported the scholarly research with unrestricted grants, acquired any involvement in the scholarly study. Data were preserved at the Myocardial Infarction Analysis Institute in Ludwigshafen, Germany, where all of the statistical analyses had been performed by independent personnel.Among the 296 women who completed treatment, there have been seven reports of mild fatigue or dizziness and three cases of incontinence. There have been no significant treatment-related complications, however. When it comes to treatment efficacy, mean Qmax improved from 13.3 mL/s at baseline to 20.4 mL/s at 4 weeks and mean postvoid residual urine declined from 75.3 mL to 54.8 mL; both adjustments were statistically significant. On the Medical Outcome Rest scale, there were significant improvements in the domains of sleep disturbance, sleep and somnolence adequacy, but no switch in hours of sleep, shortness of breath or snoring.