Educating Women About Pelvic Floor Disorders During Pregnancy

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440539
• Other study ID #: PFD Education in Pregnancy
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: June 2022
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 10, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Jul 8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolapse and Incontinence Knowledge Questionnaire (PIKQ)	Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence	< 5 minutes
Secondary	Pelvic Floor Distress Inventory (PFDI-20)	Validated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms.	< 5 minutes
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.	< 10 minutes