Stress Urinary IncontinenceNCT03808974
An Educational Video to Improve Patient Comprehension of Midurethral Sling
A study testing Educational video and Educational leaflet in people with Stress Urinary Incontinence and Knowledge, Attitudes, Practice, run by Felicia Lane at 1 site in United States.
Trial summary
The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Knowledge, Attitudes, Practice
- What is being tested?
- Educational video and Educational leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Oct 2021
- 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 scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital
Who cannot join
- < 18 years of age
- Non-English speaking or requiring interpreter assistance
- Presence of cognitive dysfunction
- Women receiving a repeat midurethral sling (not primary)
- Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Orange, California, 92628
About this study
The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.
- Being tested
- Educational video, Educational leaflet
- Medical subject headings
- Urinary Incontinence, Stress, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Short educational video describing the mid-urethral sling procedure
Educational leafletOther
Standard educational leaflet describing the mid-urethral sling procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will be shown an educational video Receives: Other: Educational video |
| Control | Active comparator | The control group will be given an educational leaflet Receives: Other: Educational leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient knowledge questionnaire (investigator-created)
The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Aug 2019
- Primary completion1 Dec 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Felicia Lane
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor-investigator, Felicia Lane, University of California, Irvine
- Investigators
- Felicia Lane, MD, Study director, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808974
- Sponsor's protocol ID
- 20184707
- Status last verified
- Sep 2023
- First submitted
- 15 Jan 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeney SES, Whitcomb EL, Ihara J, Guaderrama N, Mukhtar F, Heliker BD. A Randomized Controlled Trial Evaluating the Effect of an Educational Video on Patient Understanding of Midurethral Sling. Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):e73-e79. doi: 10.1097/SPV.0000000000001154.
PubMed 35272337
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Video to Improve Patient Comprehension of Midurethral Sling
- ClinicalTrials.gov ID
- NCT03808974
- Acronym / sponsor ID
- 20184707
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Felicia LaneUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 18 Jan 2019 (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 purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Educational videoThe intervention group will be shown an educational video |
| Control | Active comparator | Other: Educational leafletThe control group will be given an educational leaflet |
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 scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital
Key exclusion criteria (6 listed)
- < 18 years of age
- Non-English speaking or requiring interpreter assistance
- Presence of cognitive dysfunction
- Women receiving a repeat midurethral sling (not primary)
- Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
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 |
|---|---|---|
| Educational videoShort educational video describing the mid-urethral sling procedure | Other | Intervention |
| Educational leafletStandard educational leaflet describing the mid-urethral sling procedure | Other | Control |
Primary outcome
Patient knowledge questionnaire (investigator-created)
Time frame: 6 weeks
The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.
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 19 Sep 2024.
- Derived from this study: PubMed 35272337Jeney SES, Whitcomb EL, Ihara J, Guaderrama N, Mukhtar F, Heliker BD. A Randomized Controlled Trial Evaluating the Effect of an Educational Video on Patient Understanding of Midurethral Sling. Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):e73-e79. doi: 10.1097/SPV.0000000000001154.
- 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.
Felicia Lane, MD study director
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video and Educational leaflet in people with Stress Urinary Incontinence and Knowledge, Attitudes, Practice, run by Felicia Lane 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 6 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 19 Sep 2024. 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. 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 knowledge questionnaire (investigator-created) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03808974, which also lists 1 linked publication.
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 19 Sep 2024.