Educating Women About Pelvic Floor Disorders During Pregnancy

NCT05440539 | Completed Results

• 1 other identifier: PFD Education in Pregnancy
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders; Stress Urinary Incontinence; Pelvic Organ Prolapse

Keywords

pregnancy; education; prolapse; incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  < 5 minutes

Secondary Outcomes (2)

• Pelvic Floor Distress Inventory (PFDI-20)

  < 5 minutes

• Phone Interview

  < 10 minutes

Study Arms (2)

Written Group

EXPERIMENTAL

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

Workshop Group

EXPERIMENTAL

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

Interventions

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.

Workshop Group; Written Group

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.

Workshop Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant (prior to 27 weeks gestation)
• English speaking
• Greater than 18 years old

You may not qualify if:

• Non-english speaking
• unable to provide informed consent

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (8)

• Durnea CM, Khashan AS, Kenny LC, Durnea UA, Dornan JC, O'Sullivan SM, O'Reilly BA. What is to blame for postnatal pelvic floor dysfunction in primiparous women-Pre-pregnancy or intrapartum risk factors? Eur J Obstet Gynecol Reprod Biol. 2017 Jul;214:36-43. doi: 10.1016/j.ejogrb.2017.04.036. Epub 2017 Apr 23.

  PMID: 28525825 BACKGROUND

• McLennan MT, Melick CF, Alten B, Young J, Hoehn MR. Patients' knowledge of potential pelvic floor changes associated with pregnancy and delivery. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jan;17(1):22-6. doi: 10.1007/s00192-005-1325-2. Epub 2005 Jul 8.

  PMID: 16003482 BACKGROUND

• Koury H, Corral J, Bastow BD, Sheeder J, Muffly TM. A 3-Dimensional Anatomical Education Model in Postpartum Perineal Laceration Care: A Pre-Post Intervention Study. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):e23-e27. doi: 10.1097/SPV.0000000000000698.

  PMID: 30807431 BACKGROUND

• Gagnon LH, Boucher J, Robert M. Impact of pelvic floor muscle training in the postpartum period. Int Urogynecol J. 2016 Feb;27(2):255-60. doi: 10.1007/s00192-015-2822-6. Epub 2015 Aug 19.

  PMID: 26282094 BACKGROUND

• Shah AD, Massagli MP, Kohli N, Rajan SS, Braaten KP, Hoyte L. A reliable, valid instrument to assess patient knowledge about urinary incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1283-9. doi: 10.1007/s00192-008-0631-x. Epub 2008 May 15.

  PMID: 18480958 BACKGROUND

• Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.

  PMID: 16021067 BACKGROUND

• Haller J, Keller Z, Barr S, Hadden K, Oliphant SS. Assessing Readability: Are Urogynecologic Patient Education Materials at an Appropriate Reading Level? Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):139-144. doi: 10.1097/SPV.0000000000000653.

  PMID: 30807416 BACKGROUND

• Rutledge E, Spiers A, Vardeman J, Griffin N, Nisar T, Muir T, Antosh DD. Educating Women About Pelvic Floor Disorders During Pregnancy From the First to the "Fourth Trimester": A Randomized Clinical Trial. Urogynecology (Phila). 2023 Sep 1;29(9):770-776. doi: 10.1097/SPV.0000000000001341.

  PMID: 37607311 DERIVED

MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence, Stress; Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Results Point of Contact

• Title: Dr. Emily Rutledge
• Organization: Houston Methodist Hospital

erut@me.com

713-441-5800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: August 1, 2020
• Primary Completion: May 5, 2021
• Study Completion: September 10, 2021
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)