Pelvic Floor Disorders, Pelvic Organ Prolapse, Stress Urinary Incontinence
Conditions
Keywords
pregnancy, education, prolapse, incontinence
Brief summary
The purpose of this study is to assess the increase in knowledge of pregnant patients regarding pelvic floor disorders when comparing two educational interventions: written handouts vs interactive workshops.
Detailed description
Pelvic floor disorders (PFDs) are common and significantly affect the quality of life of many women as they age. Pregnancy has been identified as a major risk factor for developing PFDs later in life. Educating women about PFDs is essential to ensuring that they present to care in a timely manner. No study has investigated different education tools during pregnancy. The proposed study is a randomized controlled trial in pregnant patients comparing two educational tools: written materials about PFDs versus an educational workshops led by pelvic floor physical therapists (PFPTs). Pregnant patients will be recruited in the first and second trimester and randomized at that time. Knowledge will be assessed at baseline and again 6 weeks postpartum using the validated Prolapse and Incontinence Knowledge Questionnaire. Secondary outcomes will be evaluating referral patterns to urogynecology and to PFPTs from general OBGYNs and assessing any pelvic floor symptoms with the pelvic floor disability index (PFDI-20) at baseline and at 6 weeks postpartum.
Interventions
OTHERWritten Handouts
The written materials were generated using the collaboration of healthcare communication specialists to generate content that is tailored to a younger age demographic of childbearing age regarding their risk of developing a pelvic floor disorder and what can be done to prevent or treat them in the future.
OTHERInteractive Workshop
Participants logged onto a virtual meeting platform and listened to a live 20 minute presentation by a pelvic floor physical therapist followed by time for questions, which were answered live. Participants anonymity was maintained by not allowing participants to view each other's name and disabling sharing of video feeds.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant (prior to 27 weeks gestation) * English speaking * Greater than 18 years old
Exclusion criteria
* Non-english speaking * unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolapse and Incontinence Knowledge Questionnaire (PIKQ) | < 5 minutes | Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence. Scored out of 24 with higher scores indicating an increase in knowledge. Minimum value: 0, Maximum value: 24. Higher scores mean better outcome. Lower scores mean worse outcome. This was administrated at time of recruitment and again at 6 weeks postpartum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Distress Inventory (PFDI-20) | < 5 minutes | Validated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms. Three sub sections with a possible score of 100 for each sub section. Scaled score is a combination of the 3 sub section scores for a total possible score of 300. Higher scores indicates increased symptom bother. Minimum value: 0, Maximum value: 300. Higher scores mean better outcome. Lower scores mean worse outcome. This was administrated at time of recruitment and again at 6 weeks postpartum. |
| Phone Interview | < 10 minutes | One-on-one phone interviews conducted with participants in the workshop education group who experienced both educational tools. A research team member called them after completion of the study and conducted a brief 3 question interview to understand their opinion of the educational tools. |
Countries
United States
Participant flow
Recruitment details
Recruited between August 2020 and Sept 2021. Patients were identified via medical records and approached in an obstetrics clinic at a single institution.
Pre-assignment details
Participants were excluded if they were not english speaking or were unable to give consent due to being a minor or unable to provide consent.
Participants by arm
| Arm | Count |
|---|---|
| Written Group Participants received only written handouts with information about pelvic floor disorders, including risk factors, prevention strategies, and information about possible treatments. They receive these handouts at the time of recruitment during pregnancy and again after delivery.
Written Handouts: The written materials were generated using the collaboration of healthcare communication specialists to generate content that is tailored to a younger age demographic of childbearing age regarding their risk of developing a pelvic floor disorder and what can be done to prevent or treat them in the future. | 61 |
| Workshop Group Participants received written handouts and attend a virtual interactive workshop with information about pelvic floor disorders, including risk factors, prevention strategies, and information about possible treatments. They receive the handouts at the time of recruitment during pregnancy and again after delivery. The workshop is conducted prior to completion of pregnancy.
Written Handouts: The written materials were generated using the collaboration of healthcare communication specialists to generate content that is tailored to a younger age demographic of childbearing age regarding their risk of developing a pelvic floor disorder and what can be done to prevent or treat them in the future.
Interactive Workshop: Participants logged onto a virtual meeting platform and listened to a live 20 minute presentation by a pelvic floor physical therapist followed by time for questions, which were answered live. Participants anonymity was maintained by not allowing participants to view each other's name and disabling sharing of video feeds. | 59 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Fetal demise, no longer pregnant | 3 | 4 |
| Overall Study | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Total | Written Group | Workshop Group |
|---|---|---|---|
| Age, Continuous | 32 Years | 32 Years | 32 Years |
| Education Level College | 57 Participants | 32 Participants | 25 Participants |
| Education Level Graduate School | 53 Participants | 26 Participants | 27 Participants |
| Education Level High School | 10 Participants | 3 Participants | 7 Participants |
| Gravida | 2 Number of Pregnancies | 1 Number of Pregnancies | 2 Number of Pregnancies |
| Income Level <10,000 | 6 Participants | 1 Participants | 5 Participants |
| Income Level >100,000 | 74 Participants | 38 Participants | 36 Participants |
| Income Level 10,000-49,999 | 11 Participants | 6 Participants | 5 Participants |
| Income Level 50,000-100,000 | 29 Participants | 16 Participants | 13 Participants |
| Married | 97 Participants | 47 Participants | 50 Participants |
| Para | 1 Number of Deliveries | 1 Number of Deliveries | 1 Number of Deliveries |
| Pre-Pregnancy BMI | 26.2 kg/m2 | 27.1 kg/m2 | 25.5 kg/m2 |
| Race/Ethnicity, Customized Asian | 11 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Black | 15 Participants | 8 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic | 33 Participants | 20 Participants | 13 Participants |
| Race/Ethnicity, Customized Other (unspecified) | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 60 Participants | 28 Participants | 32 Participants |
| Region of Enrollment United States | 120 participants | 61 participants | 59 participants |
| Sex: Female, Male Female | 120 Participants | 61 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 59 |
| other Total, other adverse events | 0 / 61 | 0 / 59 |
| serious Total, serious adverse events | 0 / 61 | 0 / 59 |
Outcome results
Primary
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence. Scored out of 24 with higher scores indicating an increase in knowledge. Minimum value: 0, Maximum value: 24. Higher scores mean better outcome. Lower scores mean worse outcome. This was administrated at time of recruitment and again at 6 weeks postpartum.
Time frame: < 5 minutes
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Written Group | Prolapse and Incontinence Knowledge Questionnaire (PIKQ) | Pre-PIKQ | 17 score on a scale |
| Written Group | Prolapse and Incontinence Knowledge Questionnaire (PIKQ) | Post-PIKQ | 21 score on a scale |
| Workshop Group | Prolapse and Incontinence Knowledge Questionnaire (PIKQ) | Pre-PIKQ | 17 score on a scale |
| Workshop Group | Prolapse and Incontinence Knowledge Questionnaire (PIKQ) | Post-PIKQ | 21 score on a scale |
Secondary
Pelvic Floor Distress Inventory (PFDI-20)
Validated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms. Three sub sections with a possible score of 100 for each sub section. Scaled score is a combination of the 3 sub section scores for a total possible score of 300. Higher scores indicates increased symptom bother. Minimum value: 0, Maximum value: 300. Higher scores mean better outcome. Lower scores mean worse outcome. This was administrated at time of recruitment and again at 6 weeks postpartum.
Time frame: < 5 minutes
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Written Group | Pelvic Floor Distress Inventory (PFDI-20) | Pre-PFDI | 29.17 score on a scale |
| Written Group | Pelvic Floor Distress Inventory (PFDI-20) | Post-PFDI | 14.58 score on a scale |
| Workshop Group | Pelvic Floor Distress Inventory (PFDI-20) | Pre-PFDI | 36.47 score on a scale |
| Workshop Group | Pelvic Floor Distress Inventory (PFDI-20) | Post-PFDI | 9.89 score on a scale |
Secondary
Phone Interview
One-on-one phone interviews conducted with participants in the workshop education group who experienced both educational tools. A research team member called them after completion of the study and conducted a brief 3 question interview to understand their opinion of the educational tools.
Time frame: < 10 minutes
Population: Only the workshop group were included in the phone interview portion of the study as they experienced both interventions: written handouts and virtual workshop.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Workshop Group | Phone Interview | Preferred workshop format | 20 Participants |
| Workshop Group | Phone Interview | Preferred written format | 14 Participants |