Table 2.
Primary and secondary outcome parameters
| Primary and secondary outcomes | Baseline | Third month | Fourth month (FU with no Rx) |
|---|---|---|---|
| Patient Global Impression Index of Improvement (PGI-I) | |||
| Mace (n = 30) | 6.33 ± 0.49 | 2.76 ± 1.22b*** | 2.66 ± 1.26b*** |
| Control (n = 30) | 6.5 ± 0.62* | 5.4 ± 0.67b*** | 5.3 ± 0.6b*** |
| P value (Inter group) | >0.05a | <0.001a | <0.001a |
| Patient Global Impression of Severity (PGI-S) | |||
| Mace (n = 30) | 3.83 ± 0.37 | 2.33 ± 0.47b*** | 1.96 ± 0.49b*** |
| Control (n = 30) | 3.66 ± 0.54* | 2.93 ± 0.52b*** | 2.9 ± 0.48b*** |
| P value (Inter group) | >0.05a | <0.001a | <0.001a |
| Secondary outcomes | |||
| Urinary Distress Inventory Questionnaire (UDI-6) | |||
| Mace (n = 30) | 80.15 ± 10.26 | 29.06 ± 17.24b*** | 28.13 ± 17.74b*** |
| Control (n = 30) | 80.70 ± 12.07 | 55.18 ± 13.20b*** | 55.91 ± 13.20b*** |
| P value | 0.32a | <0.0001a | <0.0001a |
| Short form of Incontinence Impact Questionnaire-7 (IIQ-7) | |||
| Mace (n = 30) | 65.00 ± 9.75 | 19.51 ± 16.74b*** | 18.24 ± 16.96b*** |
| Control (n = 30) | 66.33 ± 13.28 | 42.84 ± 11.04b*** | 42.84 ± 11.04b*** |
| P value | 0.33a | <0.0001a | <0.0001a |
| Short form of the Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) | |||
| Mace (n = 24) | 28.91 ± 4.09 | 40.25 ± 4.80c*** | 40.91 ± 5.19c*** |
| Control (n = 20) | 27.55 ± 1.87 | 32.95 ± 2.66c*** | 33 ± 2.61c*** |
| P value | 0.07d | <0.0001d | <0.0001d |
| The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) | |||
| Mace (n = 30) | 13.76 ± 1.83 | 5.66 ± 2.60b*** | 4.56 ± 2.71b*** |
| Control (n = 30) | 14.26 ± 1.72 | 11.83 ± 1.68b** | 11.8 ± 1.75b*** |
| P value | 0.16a | <0.0001a | <0.0001a |
Data presented: mean ± SD or no. (%); *P > 0.05, considered not significant; **P < 0.05 considered significant; ***P < 0.0001, extremely significant (baseline vs. third month) & (baseline vs. follow-up); FU with no Rx: follow-up with no treatment; Test used: aMann–Whitney U test/bWilcoxon Matched paired test,cPaired/dUnpaired Student's ‘t’ test.