Chapter 3.2 46 Table 3: CST at baseline and after 4 months Laser PFMT Baseline 4 months Baseline 4 months Mean difference (95% CI) pvalue CSTa Negative 1/30 (3.3%) 12/28 (42.9%) 5/30 (16.7%) 13/26 (50%) Positive in lithotomy 20/30 (66.7%) 12/28 (42.9%) 21/30 (70%) 8/26 (30.8%) Positive in upright position 9/30 (60%) 4/28 (14.3%) 4/30 (13.3%) 5/26 (19.2%) Mean change versus baseline (95% CI) -0.57 (-0.89;-0.25) -0.31 (-0.64;0.02) -0.26 (- 0.72;0.19) 0.252 . aCST: Cough Stress Test. Change scores were calculated between 4 months follow-up and baseline; a positive change score means increase, a negative change score means decrease. Descriptive statistics are provided for the scores at baseline and 4 months. A statistical comparison between both treatment groups was performed on the change scores using a linear model. Results are presented by mean differences with 95% confidence intervals. DISCUSSION Women with mild to moderate SUI reported similar improvement in UDI-6 scores and PGI-scores following vaginal laser treatment as well as PFMT four months from baseline. Overall cure rates were low, and effects were neither long lasting: 24 months after the last treatment, more than half of patients sought additional, yet alternative, treatments. We did not observe any major safety problems. To our knowledge, this is the second randomised clinical trial comparing vaginal laser therapy with PFMT, the standard conservative management of SUI.82 Our findings align with those of da Fonseca et al., who reported comparable improvement in SUI symptoms following laser and PFMT.82 However, our study may overcome some limitations of that study. First, in that study there was no prior sample size calculation and post-hoc power calculation revealed a power of only 36%. Second, neither the primary outcome nor “cure” were clearly defined. In addition, the investigators mainly report on objective outcomes (pelvic floor strength and 1-h pad test) which are, for a condition like SUI, of less relevance to patients than subjective, patient-reported outcomes. Lastly, that study had a 20% dropout rate, potentially compromising the validity of the findings. In terms of treatment effect, we are aware of six RCTs comparing vaginal laser therapy (both fractional CO2 laser (n=4) and Er:YAG laser (n=2)) to sham procedures, however with inconsistent
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