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Educating Women About Pelvic Floor Disorders During Pregnancy

Primary Purpose

Pelvic Floor Disorders, Stress Urinary Incontinence, Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Handouts
Interactive Workshop
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Floor Disorders focused on measuring pregnancy, education, prolapse, incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Houston Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Written Group

Workshop Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence

Secondary Outcome Measures

Pelvic Floor Distress Inventory (PFDI-20)
Validated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms.
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.

Full Information

First Posted
June 28, 2022
Last Updated
June 28, 2022
Sponsor
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05440539
Brief Title
Educating Women About Pelvic Floor Disorders During Pregnancy
Official Title
Educating Women About Pelvic Floor Disorders During Pregnancy From the 1st to the "4th Trimester": A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Methodist Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Stress Urinary Incontinence, Pelvic Organ Prolapse
Keywords
pregnancy, education, prolapse, incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Written Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Workshop Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Written Handouts
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Interactive Workshop
Intervention Description
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 Outcome Measure Information:
Title
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Description
Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence
Time Frame
< 5 minutes
Secondary Outcome Measure Information:
Title
Pelvic Floor Distress Inventory (PFDI-20)
Description
Validated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms.
Time Frame
< 5 minutes
Title
Phone Interview
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28525825
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.
Results Reference
background
PubMed Identifier
16003482
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. doi: 10.1007/s00192-005-1325-2. Epub 2005 Jul 8.
Results Reference
background
PubMed Identifier
30807431
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.
Results Reference
background
PubMed Identifier
26282094
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.
Results Reference
background
PubMed Identifier
18480958
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.
Results Reference
background
PubMed Identifier
16021067
Citation
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.
Results Reference
background
PubMed Identifier
30807416
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.
Results Reference
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Educating Women About Pelvic Floor Disorders During Pregnancy

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