The Impact of a Redesigned Handout for Robotic Sacrocolpopexy on Patient Preoperative Preparedness and Satisfaction

NCT06934304 | Completed DMC

• 1 other identifier: STU-2022-0305
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a new preoperative handout for patients undergoing robotic sacrocolpopexy will improve patient sense of preparedness and satisfaction in comparison to the previously used handout. The main questions it aims to answer are:

• Does the new preoperative handout for patients undergoing robotic sacrocolpopexy improve patient preparedness and satisfaction?
• Will the new preoperative handout for patients undergoing robotic sacrocolpopexy impact postoperative queries in the form of phone calls and messages to the clinic? Participants will:
• Receive routine counseling regarding robotic sacrocolpopexy from their surgeon
• Be randomized to the new or old preoperative handout
• Undergo robotic sacrocolpopexy
• Complete a questionnaire at their 4 week postoperative follow up visit regarding their sense of preparedness for surgery and overall satisfaction

Conditions

Pelvic Organ Prolapse; Patient Satisfaction

Keywords

Robotic sacrocolpopexy handout study

Outcome Measures

Primary Outcomes (1)

• Patient preparedness

  Patients sense of preparedness for robotic sacrocolpopexy was measured with a series of 5 point Likert style questions (ranging strongly disagree to strongly agree). Specifically, patients were asked how satisfied the were with 1) information provided by their surgeon, 2) time spent with the patient preparing them for surgery, 3) overall sense of sense of preparedness.

  Assessed at the postoperative visit 4 to 6 weeks after srugery

Secondary Outcomes (1)

• patient satisfaction

  4 week postoperatively

Study Arms (2)

Old preoperative handout

PLACEBO COMPARATOR

Standard or old preoperative handout for robotic sacrocolpopexy was based off of the handout for robotic sacrocolpopexy from the American Urogynecologic Society

Other: old preoperative handout

New preoperative handout

EXPERIMENTAL

A new preoperative handout for robotic sacrocolpopexy was designed by changing the old preoperative handout such that it was written at a lower grade reading level and provided more perioperative details

Other: new preoperative handout

Interventions

new preoperative handout OTHER

A new preoperative handout for robotic sacrocolpopexy was designed at a lower reading level and providing more perioperative details

New preoperative handout

old preoperative handout OTHER

The old or standard preoperative handout for robotic sacrocolpopexy

Old preoperative handout

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women who were to undergo robotic sacrocolpopexy with or without supracervical hysterectomy, rectopexy, salpingectomy, urinary incontinence procedures, or other minor procedures.

You may not qualify if:

• patients unable to provide informed consent, those undergoing other concomitant major abdominal surgeries, patients less than 18 years old, pregnant patients, non-English speaking patients, and patients planning postoperative follow up at an outside facility.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of Texas, Southwestern Medical Center at Dallas: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Patient Satisfaction

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Fellow

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 18, 2025
• Study Start: August 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)