5 Study protocol for a randomized controlled trial: PAF-study 133 Sample size The primary outcome of the study is the tone at rest during s-EMG registration of pelvic floor. In preliminary studies we found a mean of 1.75 in rest, with a standard deviation of 1.75. Based on a slightly conservative standard deviation of 1.8, and a difference to be detected of 1.0, 70 patients in each treatment arm are required to detect a difference of 1.0 between the treatment group and the control group with postponed treatment, with a nominal alpha level of 5% and a power of 90%. Data management and data protection All medical data will be collected at the clinic before entry into the trial database. After fully signed written informed consent, data collection will be facilitated by case record forms in Castor EDC. Each participant will receive an identification code. Patients’ name and other information that can directly identify the patient, will be omitted. The PI will have a decoding list with randomization numbers and patient identification numbers in the investigator site file. Only the coordinating surgeon and PI will have access to the key to the code. All data concerning patients or their participation in this trial will be considered confidential and handled in compliance with all applicable regulations. Data will be stored in a password protected digital database. The data will be archived for 15 years after completion of the study. Data safety monitoring The Committee in Research Involving Human Subjects Leiden approved this study and declared it as a “negligible risk” study and therefore no Data Safety Monitoring Board is needed and no interim analysis or formal stopping rules for the trial are needed to be conducted or formulated. No anticipated harms exist, nor will compensation be provided for trial participation. Ethical approval and dissemination The study is conducted in accordance with the principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act (WMO) and the General Data Protection Regulation. The protocol has been approved by the Medical Ethics Review Committee of the Leiden University Medical Centre (P18.090).
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