Pelvic Organ ProlapseNCT06934304
The Impact of a Redesigned Handout for Robotic Sacrocolpopexy on Patient Preoperative Preparedness and Satisfaction
A study testing new preoperative handout and old preoperative handout in people with Pelvic Organ Prolapse and Patient Satisfaction, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Patient Satisfaction
- What is being tested?
- new preoperative handout and old preoperative handout
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women who were to undergo robotic sacrocolpopexy with or without supracervical hysterectomy, rectopexy, salpingectomy, urinary incontinence procedures, or other minor procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Randomized Controlled Study on Patient Preoperative Preparedness and Satisfaction Using a Redesigned Handout for Robotic Sacrocolpopexy
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?
Read more
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
- Being tested
- new preoperative handout, old preoperative handout
- Keywords
- Robotic sacrocolpopexy handout study
- Medical subject headings
- Pelvic Organ Prolapse, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new preoperative handoutOther
A new preoperative handout for robotic sacrocolpopexy was designed at a lower reading level and providing more perioperative details
old preoperative handoutOther
The old or standard preoperative handout for robotic sacrocolpopexy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: new preoperative handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at the postoperative visit 4 to 6 weeks after srugery
Secondary outcomes (1)
patient satisfaction
patient satisfaction for their overall experience undergoing robotic was assessed using a 5 point patient score. Scores ranged from extremely dissatisfied to extremely satisfied
Measured: 4 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Aug 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas
- Responsible party
- Principal investigator, Christine Herforth, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934304
- Sponsor's protocol ID
- STU-2022-0305
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on Patient Preoperative Preparedness and Satisfaction Using a Redesigned Handout for Robotic Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT06934304
- Acronym / sponsor ID
- STU-2022-0305
- Conditions
- Pelvic Organ Prolapse, Patient Satisfaction
- Keywords
- Robotic sacrocolpopexy handout study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Old preoperative handout | Placebo comparator | Other: old preoperative handoutStandard or old preoperative handout for robotic sacrocolpopexy was based off of the handout for robotic sacrocolpopexy from the American Urogynecologic Society |
| New preoperative handout | Experimental | Other: new preoperative handoutA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women who were to undergo robotic sacrocolpopexy with or without supracervical hysterectomy, rectopexy, salpingectomy, urinary incontinence procedures, or other minor procedures.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new preoperative handoutA new preoperative handout for robotic sacrocolpopexy was designed at a lower reading level and providing more perioperative details | Other | New preoperative handout |
| old preoperative handoutThe old or standard preoperative handout for robotic sacrocolpopexy | Other | Old preoperative handout |
Primary outcome
Patient preparedness
Time frame: Assessed at the postoperative visit 4 to 6 weeks after srugery
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.
1 secondary outcome
patient satisfaction
Time frame: 4 week postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new preoperative handout and old preoperative handout in people with Pelvic Organ Prolapse and Patient Satisfaction, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient preparedness (time frame: Assessed at the postoperative visit 4 to 6 weeks after srugery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.