Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider Counseling

This will be a randomized controlled trial comparing conventional counseling regarding pelvic organ prolapse versus an interactive patient/provider counseling process using a pelvic organ prolapse web-based tool (iPad).

All women agreeing to enroll will:

• Complete a pre-visit questionnaire querying

• Baseline satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
• Anxiety related to their presenting symptoms
• Undergo a new patient history and physical exam, including a pelvic organ prolapse quantification (POPQ) exam as per practice standard.
• Patients will then be randomized and will either receive:

• Group 1: "usual practice" counseling regarding pelvic organ prolapse
• Group 2: "usual practice" counseling in addition to interactive patient/provider counseling using the pelvic organ prolapse web-based tool (iPad)
• Complete a post-visit questionnaire before leaving the office querying:

• Post-visit satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
• Anxiety related to their presenting symptoms
• Satisfaction with counseling received regarding their presenting bulging symptoms.

Provider assessment:

The providers participating in this study will:

• Complete a pre-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.
• Watch a 2 minute video tutorial educating them on the use of the web-based interactive tool
• Complete a post-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.

Powering the Study:

Assuming a 30% difference in satisfaction with knowledge of presenting bulge symptoms/ "pelvic anatomy", this study will enroll 45 pts in each arm (total of 90 pts) to achieve a power of 80% and an alpha of 0.05.

Analytic Plan: Statistical analysis will be performed with SPSS v 19.0 (Chicago, IL) and will include, where appropriate, categorical data analysis (Pearson chi-square, Fisher's Exact),continuous data analysis (Student's t-test, Mann-Whitney-U), and Pearson correlation, and logistic regression analyses where appropriate.

DATA COLLECTION:

Data will be collected by the project personnel. Patient demographic and physical exam data will be collected by physician members of the project personnel team during the single patient-visit of this trial. The physician members of the project personnel team will perform either the "usual practice" or "usual practice" plus "interactive, web-based tool-facilitated" patient counseling. Patient and provider questionnaire data will also be collected by the project personnel team.

Number and duration of subject contact: All data will be collected over the course of a patient's single "New Patient" visit. There will be no patient follow-up after this single visit.

Inclusion criteria

Patients

• English speaking
• Women over the age of 18
• With complaints of symptomatic bulging from the vagina
• Presenting as a new patient to University of North Carolina, Chapel Hill (UNC) Urogynecology clinic

Providers

• All providers at UNC Urogynecology clinic will be allowed to participate in counseling sessions

Exclusion criteria

• Patients not meeting inclusion criteria