Chapter 6 156 Table 2. Study measures at baseline, 8-week and 20 -week follow-up. Comparison within and between treatment groups and repeated measurements PFPT group Control group Between groups 8 weeks Between groups 20 weeks Group vs Time Baseline 8 weeks p value 20 weeks p value Baseline 8 weeks p value 20 weeks p value p value p value p value EMG PF resting tone (μV), mean (SD) 6.9(2.9) 4.8(1.9) <0.001* 5.0(1.7) <0.001* 6.5(2.8) 6.1(2.3) 0.192* 4.2(1.7) <0.001* <0.001§ 0.889§ <0.001@ EMG EAS resting tone (μV), mean (SD) 6.1(2.8) 4.5(2.1) <0.001* 5.4(2.7) <0.05* 6.0(2.8) 5.8(2.7) 0.173* 4.5(2.3) <0.001* <0.05§ 0.331§ <0.001@ Fissure healed yes (%) 0.0 55.7 <0.001y 55.7 <0.001y 0.0 21.4 <0.001y 60.0 <0.001y <0.001c 0.333c NA VAS pain score, mean (SD) 5.5(1.6) 2.3(1.9) <0.001* 1.5(1.6) <0.001¢ 5.2(1.6) 4.6(1.8) <0.001* 1.5(1.6) <0.001¢ <0.001§ 0.425a <0.001@ Increased tone PF (%) 87.1 28.6 <0.001y 22.9 <0.001y 81.4 77.1 0.980y 20.0 <0.001y <0.05c 0.750c NA Proctoprom mean (SD) ¥ 5.2(2.0) 2.8(2.1) <0.001¢ 1.9(1.9) <0.001¢ 5.0(2.2) 3.8(2.2) <0.05¢ 2.4(2.1) <0.001¢ <0.001a 0.118a <0.001@ Dyssynergia DRE yes (%) 67.1 25.7 <0.001y 24.3 <0.001y 78.6 64.3 0.092y 22.9 <0.001y <0.001c 0.964c NA Dyssynergia BET yes (%) ¥ 38.6 NA NA 5.7 <0.001y 45.7 NA NA 4.3 <0.001y NA 0.566c NA Proctoprom sample sizes are 64 and 61 PFPT and control respectively at baseline, 58 and 54 respectively at 8 weeks follow-up and 44 and 45 respectively at 20 weeks follow up Dyssynergia BET sample sizes are 34 and 35 for PFPT and control respectively. At 20 weeks sample sizes are 18 PFPT vs 20 control. PFPT=Pelvic Floor Physical Therapy; EMG=Electromyography; EAS=External Anal Sphincter; VAS=Visual Analog Scale; NA= not applicable; PF=Pelvic Floor; DRE= Digital Rectal Examination; BET=Balloon Expulsion Test; PF=Pelvic Floor * Paired t-test, comparison of scores between baseline and 8 weeks and 20 weeks § Unpaired t-test comparison of change scores from baseline to week 8 and 20 weeks @ Repeated measurement analyses ¢ Wilcoxon signed rank test a Mann-Whitney U test y McNemar c Chi-square test ¥ The sample sizes shown are slightly smaller for some secondary outcomes due to missing values.
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