Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Understandability score from Patient Education Materials Assessment Tool (PMAT) questionnaire |
Percentage of positive responses to understandability questions (1-19) of the PMAT survey, where each question has a score of 0=disagree and 1=agree for each question. The sum of total points is divided by the sum of total possible points and multiplied by 100 to get percentage. A high score indicates the participant understood the material well. |
4 weeks after enrollment |
|
Primary |
Actionability score from Patient Education Materials Assessment Tool (PMAT) questionnaire |
Percentage of positive responses to actionability questions (20-26) of the PMAT survey, where each question has a score of 0=disagree and 1=agree for each question. The sum of total points is divided by the sum of total possible points and multiplied by 100 to get percentage. A high score indicates the participant was able to develop an action plan from the material. |
4 weeks after enrollment |
|
Secondary |
Recruitment Success |
Percentage of patients enrolled of all those approached for study |
At enrollment |
|
Secondary |
Retention rate |
Number of participants who remain enrolled in the study through 12 weeks postpartum. |
12 weeks postpartum |
|
Secondary |
Data completion rate |
Number of participants who return completed study questionnaire 12 weeks post partum |
12 weeks post partum |
|
Secondary |
Urinary Incontinence (UI) rate - baseline |
Number of participants scoring mild, moderate, severe or very severe incontinence on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a 3-question scale measuring UI frequency, severity and impact on quality of life with a maximum possible score of 21. 1-5 is considered mild incontinence, a score of 6-12 is considered moderate incontinence, 13-18 is considered severe incontinence and 19-21 very severe incontinence. |
at enrollment |
|
Secondary |
Urinary Incontinence (UI) rate - 34-36 weeks gestation |
Number of participants scoring mild, moderate, severe or very severe incontinence on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a 3-question scale measuring UI frequency, severity and impact on quality of life with a maximum possible score of 21. 1-5 is considered mild incontinence, a score of 6-12 is considered moderate incontinence, 13-18 is considered severe incontinence and 19-21 very severe incontinence. |
34-36 weeks gestation |
|
Secondary |
Urinary Incontinence (UI) rate - 6 weeks postpartum |
Number of participants scoring mild, moderate, severe or very severe incontinence on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a 3-question scale measuring UI frequency, severity and impact on quality of life with a maximum possible score of 21. 1-5 is considered mild incontinence, a score of 6-12 is considered moderate incontinence, 13-18 is considered severe incontinence and 19-21 very severe incontinence. |
6 weeks post partum |
|
Secondary |
Urinary Incontinence (UI) rate - 12 weeks postpartum |
Number of participants scoring mild, moderate, severe or very severe incontinence on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a 3-question scale measuring UI frequency, severity and impact on quality of life with a maximum possible score of 21. 1-5 is considered mild incontinence, a score of 6-12 is considered moderate incontinence, 13-18 is considered severe incontinence and 19-21 very severe incontinence. |
12 weeks post partum |
|
Secondary |
Adherence to Pelvic Floor Muscle Training (PFMT) - 26-28 weeks gestation |
Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises. |
26-28 weeks gestation |
|
Secondary |
Adherence to Pelvic Floor Muscle Training (PFMT) - 30-32 weeks gestation |
Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises. |
30-32 weeks gestation |
|
Secondary |
Adherence to Pelvic Floor Muscle Training (PFMT) - 34-36 weeks gestation |
Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises. |
34-36 weeks gestation |
|
Secondary |
Adherence to Pelvic Floor Muscle Training (PFMT) - 6 weeks postpartum |
Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises. |
6 weeks postpartum |
|
Secondary |
Adherence to Pelvic Floor Muscle Training (PFMT) - 12 weeks postpartum |
Sum of score on questions 1-4 of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. The maximum score is 21 with a higher score indication greater adherence to pelvic floor exercises. |
12 weeks postpartum |
|
Secondary |
Bladder Training Adherence - 6 weeks postpartum |
Number of patients indicating "yes" to the bladder training adherence question of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. A positive response indicates bladder training was used. |
6 weeks post partum |
|
Secondary |
Bladder Training Adherence - 12 weeks postpartum |
Number of patients indicating "yes" to the bladder training adherence question of the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. A positive response indicates bladder training was used. |
12 weeks post partum |
|
Secondary |
Voiding interval - 6 weeks postpartum |
Change in estimated number of minutes between urinations after completing bladder training, as reported on the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. |
6 weeks post partum |
|
Secondary |
Voiding interval - 12 weeks postpartum |
Change in estimated number of minutes between urinations after completing bladder training, as reported on the Pelvic Floor Muscle Exercise and Bladder Training Adherence questionnaire. |
12 weeks post partum |
|
Secondary |
Barriers to Use of bladder training - 6 weeks postpartum |
Numbers of patients reporting each of 4 possible reasons as barriers to use of bladder training: Average time between urinations was as recommended, it was too complicated to fit into daily life, it was not a technique the participant wanted to try, or other. |
6 weeks post partum |
|
Secondary |
Barriers to Use of bladder training - 12 weeks postpartum |
Numbers of patients reporting each of 4 possible reasons as barriers to use of bladder training: Average time between urinations was as recommended, it was too complicated to fit into daily life, it was not a technique the participant wanted to try, or other. |
12 weeks post partum |
|