Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Physical function |
Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Other |
Fatigue |
Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Other |
Pain interference |
Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Other |
Depressive symptoms |
Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Other |
Anxiety |
Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Other |
Ability to participate in social roles and activities |
Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Other |
Sleep disturbances |
Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Other |
Preoperative expectations/importance of sexual function recovery |
Will use a linear mixed effects model of sexual function scores measured post-baseline through 12 months, adjusted for baseline sexual function score to evaluate if preoperative expectation/importance of sexual function recovery is associated with outcomes over time. |
Baseline |
|
| Primary |
Preoperative sexual function |
Assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Brief Profile Sexual Function and Satisfaction version 2 (v2.0). Will utilize descriptive statistics to report preoperative sexual function. Frequencies and percentages will be reported for categorical variables and mean (standard deviation) or median (interquartile range) for continuous variables. |
Baseline |
|
| Primary |
Interest in sexual activity |
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Primary |
Lubrication |
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Primary |
Vaginal discomfort |
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Primary |
Satisfaction with sex life |
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Secondary |
Labial discomfort |
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Secondary |
Clitoral discomfort |
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Secondary |
Orgasm ability |
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Secondary |
Orgasm pleasure |
Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points. |
From baseline to 3, 6, and 12 months |
|
| Secondary |
Change in sexual function scores |
Will use a linear mixed effects model of 12-month sexual function scores adjusting for baseline function to evaluate independent variables of interest related to the surgical procedure: age, robotic/open approach, pelvic organ sparing and diversion type. Variables of interest will be analyzed separately. In the analysis of robotic vs. open approach, the model will include terms for time (after surgery: 3, 6, and 12 months, using a discrete time formulation), approach (robotic=1, open=0), and approach by time interaction. Contrasts of the interaction and main effects will allow estimation of whether outcomes at 12 months differ by approach. |
From baseline to 12 months |
|
