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List inclusion criteria for fibroids (ie, fibroids identified by clinical exam, symptoms, imaging. Any size or location criteria for fibroids for study inclusion) | |

List inclusion criteria for PFDs (ie, any specific symptoms that were required for inclusion in to the study specific to pelvic floor) | |

List other inclusion criteria |

Arm Name | Arm Description |
---|---|

High intensity focused ultrasound | Abbreviated as HIFU in many papers |

Lower Limit | Higher Limit | |
---|---|---|

Mean | ||

95% CI | ||

Standard Deviation (SD) | ||

Standard Error (SE) | ||

Median | ||

Interquartile Range (IQR) | ||

Full range |

Lower Limit | Higher Limit | |
---|---|---|

Mean | ||

95% CI | ||

Standard Deviation (SD) | ||

Standard Error (SE) | ||

Median | ||

Interquartile Range (IQR) | ||

Full range |

Lower Limit | Higher Limit | |
---|---|---|

Mean | ||

95% CI | ||

Standard Deviation (SD) | ||

Standard Error (SE) | ||

Median | ||

Interquartile Range (IQR) | ||

Full range | ||

n (%) |

Not reported/ Unable to calculate | |

White (all), % | |

White, Non-Hispanic, % | |

Black/AA (all), % | |

Black/AA, Non-Hispanic, % | |

Hispanic/Latina, % | |

Asian, % | |

Other_1, % | |

Other_2, % | |

Other_3, % | |

Other_4, % |

Lower Limit | Higher Limit | |
---|---|---|

Mean | ||

95% CI | ||

Standard Deviation (SD) | ||

Standard Error (SE) | ||

Median | ||

Interquartile Range (IQR) | ||

Full range | ||

Units |

Lower Limit | Higher Limit | |
---|---|---|

Mean | ||

95% CI | ||

Standard Deviation (SD) | ||

Standard Error (SE) | ||

Median | ||

Interquartile Range (IQR) | ||

Full range |

Lower Limit | Higher Limit | |
---|---|---|

Mean | ||

95% CI | ||

Standard Deviation (SD) | ||

Standard Error (SE) | ||

Median | ||

Interquartile Range (IQR) | ||

Full range | ||

Units |

Anterior | |

Posterior | |

Fundal | |

Cervical | |

Other | |

Not Reported (NR) |

AUB/HMB/menorrhagia | |

Abdominal/pelvic pressure | |

Pelvic pain or Dyspareunia | |

“Bulk” symptoms | |

Urinary symptoms | |

Other | |

Not Reported (NR) |

P value | Difference | |
---|---|---|

All NS (or NR) | ||

Age | ||

BMI | ||

Parity | ||

Race/ethnicity | ||

Uterine size | ||

No. fibroids | ||

Size of fibroids | ||

Location of fibroids | ||

Fibroid Sxs | ||

Comorbidities | ||

Other |

- All Participants
- Baseline
- 3 months
- All Participants
- Baseline
- 3 (mo)

Type | Domain | Specific measurement (i.e., tool/definition/specific outcome) | Populations | Timepoints |
---|---|---|---|---|

Continuous | UDI-6 | Urinary distress Inventory 6 (UDI-6) | ||

Continuous | IIQ-7 | Incontinence Impact Questionnaire, Short Form (IIQ-7) |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Rating | |

Notes/Comments |

Descriptive Statistics | Between Arm Comparisons | |||
---|---|---|---|---|

High intensity focused ultrasound | ||||

Baseline | ||||

Total UDI-6 Score | Mean Difference (MD) | |||

Question 7: Feelings of frustration | 95% CI low (MD) | |||

Question 6: Emotional health | 95% CI high (MD) | |||

Question 5: Participation in social activities outside your home | SD (MD) | |||

Question 4: Ability to travel by car or bus >30 min from home | p value (MD) | |||

Question 3: Entertainment activities | ||||

Question 2: Physical recreation | ||||

Question 1: Ability to do household chores | ||||

Total IIQ-7 Score | ||||

Question 6: Pain or discomfort in lower abdominal or genital area | ||||

Question 5: Difficulty emptying bladder | ||||

Question 4: Small amount of leakage | ||||

Question 3: Leakage related to physical activity, coughing, or sneezing | ||||

Question 2: Urine leakage associated with feeling or urgency | ||||

Question 1: Frequent urination | ||||

Total (N analyzed) | ||||

Mean | ||||

SD | ||||

3 months | ||||

Total UDI-6 Score | Mean Difference (MD) | |||

Question 7: Feelings of frustration | 95% CI low (MD) | |||

Question 6: Emotional health | 95% CI high (MD) | |||

Question 5: Participation in social activities outside your home | SD (MD) | |||

Question 4: Ability to travel by car or bus >30 min from home | p value (MD) | |||

Question 3: Entertainment activities | ||||

Question 2: Physical recreation | ||||

Question 1: Ability to do household chores | ||||

Total IIQ-7 Score | ||||

Question 6: Pain or discomfort in lower abdominal or genital area | ||||

Question 5: Difficulty emptying bladder | ||||

Question 4: Small amount of leakage | ||||

Question 3: Leakage related to physical activity, coughing, or sneezing | ||||

Question 2: Urine leakage associated with feeling or urgency | ||||

Question 1: Frequent urination | ||||

Total (N analyzed) | ||||

Mean | ||||

SD | ||||

Within Arm Comparisons | Net Comparisons | |||

High intensity focused ultrasound | ||||

vs. | ||||

p value UDI-6 Question 1 | Saved! | Net Mean Difference (NMD) | ||

p value UDI-6 Question 2 | Saved! | 95% CI low (NMD) | ||

p value UDI-6 Question 3 | Saved! | 95% CI high (NMD) | ||

p value UDI-6 Question 4 | Saved! | SD (NMD) | ||

p value UDI-6 Question 5 | Saved! | P value (NMD) | ||

p value UDI-6 Question 6 | Saved! | |||

p value UDI-6 Total score | Saved! | |||

p value IIQ-7 Question 1 | Saved! | |||

p value IIQ-7 Question 2 | Saved! | |||

p value IIQ-7 Question 3 | Saved! | |||

p value IIQ-7 Question 4 | Saved! | |||

p value IIQ-7 Question 5 | Saved! | |||

p value IIQ-7 Question 6 | Saved! | |||

p value IIQ-7 Question 7 | Saved! | |||

p value IIQ-7 Total score | Saved! |

Descriptive Statistics | Between Arm Comparisons | |||
---|---|---|---|---|

High intensity focused ultrasound | ||||

Baseline | ||||

Question 1: Ability to do household chores | Mean Difference (MD) | |||

Question 2: Physical recreation | 95% CI low (MD) | |||

Question 3: Entertainment activities | 95% CI high (MD) | |||

Question 4: Ability to travel by car or bus >30 min from home | SD (MD) | |||

Question 5: Participation in social activities outside your home | p value (MD) | |||

Question 6: Emotional health | ||||

Question 7: Feelings of frustration | ||||

Total IIQ-7 Score | ||||

Total (N analyzed) | ||||

Mean | ||||

SD | ||||

3 (mo) | ||||

Question 1: Ability to do household chores | Mean Difference (MD) | |||

Question 2: Physical recreation | 95% CI low (MD) | |||

Question 3: Entertainment activities | 95% CI high (MD) | |||

Question 4: Ability to travel by car or bus >30 min from home | SD (MD) | |||

Question 5: Participation in social activities outside your home | p value (MD) | |||

Question 6: Emotional health | ||||

Question 7: Feelings of frustration | ||||

Total IIQ-7 Score | ||||

Total (N analyzed) | ||||

Mean | ||||

SD | ||||

Within Arm Comparisons | Net Comparisons | |||

High intensity focused ultrasound | ||||

Baseline vs. 3 mo | ||||

p value IIQ-7 Question 1 | Saved! | Net Mean Difference (NMD) | ||

p value IIQ-7 Question 2 | Saved! | 95% CI low (NMD) | ||

p value IIQ-7 Question 3 | Saved! | 95% CI high (NMD) | ||

p value IIQ-7 Question 4 | Saved! | SD (NMD) | ||

p value IIQ-7 Question 5 | Saved! | P value (NMD) | ||

p value IIQ-7 Question 6 | Saved! | |||

p value IIQ-7 Question 7 | Saved! | |||

p value IIQ-7 Total score | Saved! |