Materials and methods
SUI, TVT, cough stress, incontinence
RECRUITMENT, INCONTINENCE, URINARY INCONTINENCE, PAD, LEAKAGE
We conducted a prospective, randomized, controlled, parallel-group, non-inferiority trial comparing TVT and PAHG for primary SUI at Helsinki University Hospital. We recruited patients referred from primary healthcare with positive cough stress test, insufficient response after pelvic floor muscle physiotherapy, and eligible for TVT operation. Pelvic floor muscle therapy (PFMT) is the first-line treatment according to Finnish national guidelines on urinary incontinence, and women who were referred to our clinic had been earlier supervised by a health care professional or physiotherapist for PFMT, and due to inadequate response were seeking for operative treatment. Recruitment took place between September 28, 2015 and March 1, 2017. Study inclusion criteria included SUI not responsive to conservative treatment, patient age greater than 18 years, no previous incontinence procedure, a positive cough stress test without urge-type leakage, PVR volume less than 100 ml, and bladder capacity greater than 300 ml. In addition to the clinically used cough stress test, we used a pad test to confirm SUI [The primary noninferiority outcome of our study was patient satisfaction with the treatment ≥ 80, as measured by a VAS from 0 (extremely unsatisfied) to 100 (extremely satisfied) [The sample size was calculated for the primary outcome, estimating that patient satisfaction with the treatment result of ≥ 80 on VAS from 0–100 was a good outcome. Based on earlier studies, the sample size was calculated to test two portions for noninferiority, setting the patient satisfaction with the treatment 80% in the TVT group and 75% in the PAHG group, assuming 5% unit predominance for TVT group [We analyzed data using IBM SPSS Statistics, version 24.0 (SPSS Inc., Chicago IL, USA). We present data from the questionnaires as means ± SD. We used the Student’s 