修改后的方案能否审查通过就难说了。
如果修改后的方案仍无对照、Primary Outcome仍设为Reproducible bladder contraction,那么他们的方案不可能复查通过。
他们应该向丹麦Aarhus University学习:
http://clinicaltrials.gov/ct2/show/study/NCT01274312?show_desc=Y#descBefore the widespread use of somato-sensory reflex arch we find it of utmost importance that well designed studies with validated or even objective endpoints are performed. Results of such studies will have an international impact in either defining indications for a completely new treatment principle or, otherwise, in preventing the widespread use of an ineffective treatment.