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Completed

NCT Number: NCT05440539

Educating Women About Pelvic Floor Disorders During Pregnancy

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.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Pregnancy Complications Prolapse Signs and Symptoms Stress Urinary Incontinence Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written Handouts

Other

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

Other

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.

Primary outcomes

  1. Prolapse and Incontinence Knowledge Questionnaire (PIKQ)

    Time frame: < 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 outcomes

  1. Pelvic Floor Distress Inventory (PFDI-20)

    Time frame: < 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.

  2. Phone Interview

    Time frame: < 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.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Educating Women About Pelvic Floor Disorders During Pregnancy From the 1st to the "4th Trimester": A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2022
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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