An interventional study of Written Handouts and Interactive Workshop in Pelvic Floor Disorders, Stress Urinary Incontinence and Pelvic Organ Prolapse, sponsored by The Methodist Hospital Research Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by The Methodist Hospital Research Institute · Not applicable, Interventional, and Other
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 120 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →The Methodist Hospital Research Institute is the lead sponsor of 157 studies on the registry; 60 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 15 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Written Handouts
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.
Other: Written Handouts · Other: Interactive Workshop
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.
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.
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
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
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
Recruited between August 2020 and Sept 2021. Patients were identified via medical records and approached in an obstetrics clinic at a single institution.
| Milestone | Written Group | Workshop Group |
|---|---|---|
| Started | 61 | 59 |
| Completed | 54 | 51 |
| Not completed | 7 | 8 |
| Withdrew: Lost to follow-up | 4 | 4 |
| Withdrew: Fetal demise, no longer pregnant | 3 | 4 |
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.
| score on a scale | Written Group | Workshop Group |
|---|---|---|
| Pre-PIKQ | 17 (14 to 22) | 17 (13 to 20) |
| Post-PIKQ | 21 (19 to 23) | 21 (17 to 22) |
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.
| score on a scale | Written Group | Workshop Group |
|---|---|---|
| Pre-PFDI | 29.17 (12.50 to 64.58) | 36.47 (17.71 to 62.50) |
| Post-PFDI | 14.58 (0 to 25) | 9.89 (3.13 to 22.92) |
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.
| Participants | Written Group | Workshop Group |
|---|---|---|
| Preferred workshop format | — | 20 |
| Preferred written format | — | 14 |
Collected over August 2020 until September 2021 Participants were recruited in the 1st and 2nd trimester of pregnancy and remained in the study until 6 weeks postpartum. The estimated time of involvement in the study was between 6-8 months depending on the point in pregnancy at which they were recruited.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Written Group | 0/61 (0%) | 0/61 (0%) | 0/61 (0%) |
| Workshop Group | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Age, Continuous(Years) | Written Group | Workshop Group | Total |
|---|---|---|---|
| Median | 32 (30 to 37) | 32 (29.5 to 35) | 32 (19 to 53) |
| Sex: Female, Male(Participants) | Written Group | Workshop Group | Total |
|---|---|---|---|
| Female | 61 | 59 | 120 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Written Group | Workshop Group | Total |
|---|---|---|---|
| White | 28 | 32 | 60 |
| Hispanic | 20 | 13 | 33 |
| Black | 8 | 7 | 15 |
| Asian | 4 | 7 | 11 |
| Other (unspecified) | 1 | 0 | 1 |
| Region of Enrollment(participants) | Written Group | Workshop Group | Total |
|---|---|---|---|
| United States | 61 | 59 | 120 |
| Income Level(Participants) | Written Group | Workshop Group | Total |
|---|---|---|---|
| <10,000 | 1 | 5 | 6 |
| 10,000-49,999 | 6 | 5 | 11 |
| 50,000-100,000 | 16 | 13 | 29 |
| >100,000 | 38 | 36 | 74 |
| Gravida(Number of Pregnancies) | Written Group | Workshop Group | Total |
|---|---|---|---|
| Median | 1 (1 to 2.5) | 2 (1 to 3) | 2 (1 to 6) |
| Para(Number of Deliveries) | Written Group | Workshop Group | Total |
|---|---|---|---|
| Median | 1 (1 to 2) | 1 (1 to 2) | 1 (1 to 5) |
| Pre-Pregnancy BMI(kg/m2) | Written Group | Workshop Group | Total |
|---|---|---|---|
| Median | 27.1 (24.1 to 30.9) | 25.5 (22.65 to 30.35) | 26.2 (19.6 to 55.8) |
2 further baseline measures are reported on the registry.
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