Study design
This was a secondary analysis of a parallel-group, assessor-blinded randomized controlled trial (RCT) with the primary aim of examining the effects of postpartum PFMT on the rate of postpartum urinary incontinence (UI) and anal incontinence (AI) in primiparous women.13 The trial was carried out at a Physiotherapy Clinic in the Reykjavik Capital Area, from March 2016 to January 2018. Baseline assessments and background data of participants were obtained at recruitment 9 weeks postpartum (range 6-13 weeks). Short-term outcomes were completed at the end of treatment at around 6 months (range 5-7), and long-term outcomes were investigated at 12 months (range 11-14) postpartum.
The study was approved by the Icelandic National Bioethics Committee (Ref: VSN-13-189), the Icelandic Data Protection Authority (Ref: 2014030475TS/–) and registered at https://register.clinicaltrials.gov (NCT02682212). The study was conducted according to the Helsinki declaration on human experimentation. All participants provided a signed informed consent. Delivery and maternal data were obtained from the Icelandic Medical Birth Register.