Participants
A prospective randomized controlled trial (RCT) was undertaken via Czech
tertiary referral at the Brno University Hospital Urogynecology Center
from January 2015 thru December 2019. This non-blinded study involved
Caucasian (central European) women with pure urodynamic SUI confirmed
during cystometry by a positive standardized cough stress test (CST)
with urinary bladder filling of 250 ml in lithotomy position. Patients
with urgency or predominant urgency incontinence, intrinsic sphincter
deficiency (MUCP<20 cmH2O), and pelvic organ prolapse
(POP-Q>2) were excluded from the study. Further exclusion
criteria were previous SUI surgery or pelvic organ prolapse (POP)
surgery and presence of other pelvic organ pathology. Study was approved
by our university hospital Ethical Review Board. Written informed
consent for study enrollment was collected from all participants. The
study was supported by the National Ministry of Health (Project Number
FNBr65269705). The funder (through their peer review and funding board
review process) approved the study proposal but had no role in the
collection, analysis, or interpretation of data, or writing of the
report.