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Video Decision Aid in Latina Women With Pelvic Organ Prolapse

Role of Video Decision Aid in Pelvic Organ Prolapse Treatment Selection in Latina Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02850835
Enrollment
33
Registered
2016-08-01
Start date
2016-07-31
Completion date
2018-12-31
Last updated
2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Decision Aid, Pelvic Organ Prolapse (POP)

Brief summary

Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP in a border region university-affiliated medical clinic, will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment.

Detailed description

Pelvic organ prolapse (POP) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. Latina women are disproportionally affected, with significantly higher rates of POP compared to women of other ethnicities. Counseling Latina women suffering from POP is often complex due to a variety of factors, including language barriers, limited patient understanding of anatomy and disease etiology and confusion regarding surgical versus nonsurgical treatment options. Decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. The investigators hypothesize that the use of a video decision aid prior to initial Urogynecology specialist evaluation of Latina women with POP will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment, empowering these women as active participants in their healthcare instead of relying on provider input alone.

Interventions

A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.

Sponsors

Texas Tech University Health Sciences Center, El Paso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hispanic Women * Referred for evaluation of pelvic organ prolapse for the first time

Exclusion criteria

* Women previously referred or treated for pelvic organ prolapse * Women who do not live in El Paso, Texas

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline decisional conflict score at 6 months.6 monthsDecisional Conflict Scale will be used

Secondary

MeasureTime frameDescription
Change from baseline knowledge of condition score at 6 months.6 months12-item questionnaire of female pelvic anatomy and pelvic organ prolapse concepts will be used
Change from baseline satisfaction with selected treatment at 6 months.6 monthsSatisfaction with Decision Scale-(PFD) will be used

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026