Pelvic Floor Disorder Education in Prenatal Care

NCT05127512 | Completed

• 1 other identifier: STUDY-20-03435
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Pelvic floor disorders (PFDs) are common conditions that can have significant impacts on patients' quality of life and psychosocial well-being. It is well known that patients who have experienced pregnancy and childbirth are at risk of developing these conditions, either during pregnancy, postpartum, or later in life. However, many women are unaware of this predisposing risk factor. Additionally, overall knowledge of these conditions is low in both the general and obstetrics population. Video education has been used in various fields with success in improving patient knowledge of specific topics and conditions. To the researchers' knowledge, no studies have evaluated this modality for educating obstetrics patients on PFDs. The aim of this study is to determine whether the use of an educational video will improve knowledge of PFDs compared to routine prenatal counseling, using a validated knowledge questionnaire.

Conditions

Pelvic Floor Disorders

Keywords

Pelvic floor disorders; Education; Prenatal education; Video education

Outcome Measures

Primary Outcomes (1)

• Change in Prolapse and Incontinence Knowledge Questionnaire

  The questionnaire is divided into two separate 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP). Subscales from 0 to 12. Total scale from 0-24. A higher score indicates higher proficiency.

  Baseline, 1 day ( the time of enrollment) and at 6-8 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Control participants will only complete the knowledge questionnaire in addition to a non-validated survey created by the investigators to collect demographic information as well as attitudes towards treatments of pelvic floor disorders.

Video Group

EXPERIMENTAL

These participants will be administered the study intervention, which entails viewing an education video on pelvic floor disorders.

Other: Education Video

Interventions

Education Video OTHER

A 6.47-minute education video was created by the research group based on American Urogynecology Society (AUGS) and International Urogynecologic Association (IUGA) patient education pamphlets. Participants in the intervention group will be asked to watch this video after completing a baseline knowledge questionnaire of pelvic floor disorders.

Video Group

Eligibility Criteria

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

You may qualify if:

• Women 18 years or older in their third trimester of pregnancy (37 weeks of gestation or greater)
• English-speaking

You may not qualify if:

• Non-English-speaking patients
• Gestational age \< 37 weeks

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (5)

• Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.

  PMID: 24807341 BACKGROUND

• Hyakutake MT, Han V, Cundiff GW, Baerg L, Koenig NA, Lee T, Geoffrion R. Pelvic Floor Health Education: Can a Workshop Enhance Patient Counseling During Pregnancy? Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):336-9. doi: 10.1097/SPV.0000000000000285.

  PMID: 27171319 BACKGROUND

• Geoffrion R, Robert M, Ross S, van Heerden D, Neustaedter G, Tang S, Milne J. Evaluating patient learning after an educational program for women with incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1243-52. doi: 10.1007/s00192-009-0919-5. Epub 2009 Jun 11.

  PMID: 19517050 BACKGROUND

• Howell EA. Lack of patient preparation for the postpartum period and patients' satisfaction with their obstetric clinicians. Obstet Gynecol. 2010 Feb;115(2 Pt 1):284-289. doi: 10.1097/AOG.0b013e3181c8b39b.

  PMID: 20093900 BACKGROUND

• Liu J, Tan SQ, Han HC. Knowledge of pelvic floor disorder in pregnancy. Int Urogynecol J. 2019 Jun;30(6):991-1001. doi: 10.1007/s00192-019-03891-3. Epub 2019 Feb 19.

  PMID: 30783706 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Chandhu Paka, MD

  Mount Sinai West

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 19, 2021
• Study Start: October 25, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to bhgaigbe@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website tbd.

Locations

US (1)