Material and Methods
Our institutional review board approved this prospective, randomized, controlled trial. From May 2009 to May 2010, 121 consecutive patients who had undergone laparoscopic RP for PCa were assessed for eligibility. The inclusion criteria were male patients aged ≥65 years, clinically localized PCa (cT1-T2), Eastern Cooperative Oncology Group performance status of 0 or 1, and written informed consent. The exclusion criteria were adjuvant or neoadjuvant therapy, severe postoperative complications, a history of intrapelvic surgery, diseases that can affect voiding function, and limitations for exercise intervention, such as patients with serious cardiovascular events or spinal or articular disease.
We performed a preliminary study, which was published in a Korean journal.6 The sample size was calculated by differences between each group using the preliminary data. Our initial estimate for the study included 30 patients in each group for a power of 80% to detect a 40% increase in the treatment group. A random number generator was used to determine the randomization allocation in a 1:1 ratio; this was printed on paper and placed in a sealed envelope, sequentially numbered, and opened by the trial nurse before the pre-exercise measurement.