Table 2.
Baseline characteristics according to treatment group
| 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 | < 0.001ψ | 55.7 | < 0.001ψ | 0.0 | 21.4 | < 0.001ψ | 60.0 | < 0.001ψ | < 0.001χ | 0.333χ | 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§ | 0.425α | < 0.001@ |
| Increased tone PF (%) | 87.1 | 28.6 | < 0.001ψ | 22.9 | < 0.001ψ | 81.4 | 77.1 | 0.980ψ | 20.0 | < 0.001ψ | < 0.05χ | 0.750χ | 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¢ | < 0.001α | 0.118α | < 0.001@ |
| Dyssynergia DRE yes (%) | 67.1 | 25.7 | < 0.001ψ | 24.3 | < 0.001ψ | 78.6 | 64.3 | 0.092ψ | 22.9 | < 0.001ψ | < 0.001χ | 0.964χ | NA |
| Dyssynergia BET yes (%) | 38.6 | NA | NA | 5.7 | < 0.001ψ | 45.7 | NA | NA | 4.3 | < 0.001ψ | NA | 0.566χ | 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
αMann-Whitney U test
ψMcNemar
χChi-square test
¥The sample sizes shown are slightly smaller for some secondary outcomes due to missing values.