Stress Urinary IncontinenceMUViNCT03198481
Patient-Centered Versus Physician-Centered Counseling MidUrethral Sling Videos
A study testing Patient-Centered Counseling Video and Physician Counseling Video in people with Stress Urinary Incontinence and Satisfaction, run by University of New Mexico at 2 sites in United States.
Trial summary
The decision making process for stress incontinence surgery is complex. A key gap in the literature is how to improve patient preparedness and satisfaction for mid-urethral sling (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence, Satisfaction
- What is being tested?
- Patient-Centered Counseling Video and Physician Counseling Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 28 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are ≥ 18 years of age
- Planning to undergo a midurethral sling procedure
- Either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a positive cough stress test or SUI documented on urodynamic testing
- English speaking
Who cannot join
- Those who desire a concomitant POP Surgery
- Inability to speak/understand English
- Prior midurethral sling performed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico
Albuquerque, New Mexico, 87110
Dell Medical School at University of Texas at Austin
Austin, Texas, 78705
About this study
Official title: Protocol for Patient-Centered Versus Physician-Centered Counseling Video for Midurethral Slings an RCT
The decision making process for stress incontinence surgery is complex. A key gap in the literature is how to improve patient preparedness and satisfaction for mid-urethral sling (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap. The specific aims of the proposed research: (1) is to develop two videos to counsel patients who have elected to undergo a MUS surgery. One video will be created from a patient-centered perspective using peers as counselors. The second will employ a traditional counseling approach; (2) To compare the impact of multimedia counseling between women randomized to a patient-centered counseling versus a traditional counseling video. The investigators will recruit patients who present with stress urinary incontinence who elect to undergo a MUS procedure. Women will be randomized during their pre-operative visit to watch the patient-centered or traditional counseling video before they are counseled regarding their upcoming MUS surgery in the usual manner. The investigators anticipate women randomized to a patient centered-video will report higher satisfaction, less decisional regret, greater preparedness, and less anxiety as measured by validated scales. Successful completion will improve understanding of patient's needs and will allow development of improved educational tools readily available to the AUGS community.
Read the detailed description
Management of Pelvic Floor Disorders (PFDs) is individualized according to a patient's symptomatology and quality of life. Although conservative measures exist, patients may elect for surgical management. The decision making process for surgery is complex. It is well documented that patient's lack understanding prior to their surgical procedures. Preparedness for MUS surgery is related to a patient's comprehension of the purpose, risks, benefits, and complications. Patients who are more prepared prior to surgery have been proven to have greater postoperative satisfaction. Therefore, it is essential to improve patients' preparedness and enhance patients' understanding of realistic expectations of post-operative outcomes.
The investigators long-term goal is to improve patient-centered preparedness and satisfaction when considering surgery. Previous studies by the Preliminary Study of Peer Support Groups and Pelvic Floor Disorders have demonstrated trends in improvement for preparedness and decision conflict with the use of peer focus groups. However, peer support groups are a costly process and there may be many barriers to participation.
A key gap in the literature is how to improve patient preparedness for surgery and improve satisfaction through the use of peer counseling in a manner that is convenient for patients, reproducible and low cost. Technological advances with multimedia may assist in bridging this gap. With ease-of-access to mobile electronic devices, videos are effective tools to prepare patients for surgery. The purpose of this randomized controlled clinical trial is to determine if a patient-centered video improves satisfaction and preparedness compared to a physician-centered video.
The first objective of this research is to develop two videos to counsel patients who have elected to undergo a MUS procedure. One video will be created from a physician-centered approach. The second video will be a patient-centered perspective. The second objective of this research is to compare the impact of video counseling between women randomized to a physician-centered versus a patient-centered video. The central hypothesis is that women randomized to a patient-centered video will report higher scores of satisfaction and preparedness than women randomized to the physician-centered video.
Specifically, our aims for this study are:
- To create two videos to be used to counsel patients who have elected to undergo a MUS procedure. One video will present the risks, benefits and alternatives to MUS surgery by a physician, mimicking traditional counseling prior to surgery. The second video will explain the risks, benefits and alternatives to the MUS surgery utilizing a patient mentor who has undergone the MUS procedure and will describe the patients' perception of the information. The patient-centered video will also include topics that have previously been identified by focus groups as important patient-centered aspects of pre-surgical counseling.
- To compare the impact of video counseling between women randomized to a physician-centered video and a patient-centered video. Hypothesis: Women randomized to a patient centered-video will report higher satisfaction and preparedness as measured by validated scales. They will have higher scores on the Post-operative preparedness questionnaire (PPQ), Preparedness Scale and the Surgical Decision Satisfaction (SDS-PFD) questionnaire; and lower scores on the Decision Regret Scale (DRS-PFD) questionnaire than women randomized to view the physician-centered video prior to undergoing mid-urethral sling surgery.
- To compare a women's decisional conflict post-operatively in women randomized to the physician-centered video and the patient-centered video. Hypothesis: There is a reduction of decisional conflict in women randomized to the patient-centered video.
- To determine if there are differences in anxiety scores in women who watch the patient-centered video versus the physician centered video. Hypothesis: Anxiety scores measured by the State Trait Anxiety Inventory (STAI: Y-6 Item) questionnaire are decreased by a pre-operative patient-centered counseling video.
- Conditions
- Stress Urinary Incontinence, Satisfaction
- Being tested
- Patient-Centered Counseling Video, Physician Counseling Video
- Keywords
- midurethral sling, movie, preparedness, Video Counseling
- Medical subject headings
- Urinary Incontinence, Stress, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Centered Counseling VideoBehavioural
Patients will watch a patient-centered education video regarding MUS prior to standard pre-operative counseling.
Physician Counseling VideoBehavioural
Patients will watch a physician-centered video regarding MUS prior to standard pre-operative counseling.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Centered Counseling Video Group | Active comparator | MUS video utilizing a patient mentor. Receives: Behavioral: Patient-Centered Counseling Video |
| Physician Counseling Video Group | Active comparator | MUS video by a physician. Receives: Behavioral: Physician Counseling Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preparedness
The objective is to compare patient preparedness between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report higher preparedness pre-operative and 6 weeks post-operative on the Patient Preparedness Questionnaire (PPQ). The investigators will assess the level of pre-operative and post-operative preparedness according to each preparedness question on the Patient Preparedness Questionnaire (PPQ).
Measured: Change from baseline at the 6 weeks post-operative visit
Secondary outcomes (2)
Patient Satisfaction
The objective is to compare patient satisfaction between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report higher satisfaction scores pre-operative and 6 weeks post-operative. Satisfaction will be measured by the Satisfaction with Decision Scale-Pelvic Floor Disorders (SDS-PFD) at her pre-operative visit and at the subjects 6 week visit.
Measured: Change from baseline at the 6 weeks post-operative visit
Decision Regret
The objective is to compare patient decision regret between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report less decision regret at their 6 weeks post-operative visit. Decision regret will be evaluated using the Decision Regret Scale-Pelvic Floor Disorders (DRS-PFD) and at the subjects 6 week visit.
Measured: 6 weeks post-operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Jul 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuko M Komesu, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198481
- Sponsor's protocol ID
- 17-058
- Acronym
- MUVi
- Status last verified
- Dec 2024
- First submitted
- 25 May 2017
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reading AE. Psychological preparation for surgery: patient recall of information. J Psychosom Res. 1981;25(1):57-62. doi: 10.1016/0022-3999(81)90084-2. No abstract available.
PubMed 7277269Pool JJ. Expected and actual knowledge of hospital patients. Patient Couns Health Educ. 1980 3d Quart;2(3):111-7. doi: 10.1016/s0738-3991(80)80051-6. No abstract available.
PubMed 10249187Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.
PubMed 18060968Brubaker L, Litman HJ, Rickey L, Dyer KY, Markland AD, Sirls L, Norton P, Casiano E, Paraiso MF, Ghetti C, Rahn DD, Kusek JW. Surgical preparation: are patients "ready" for stress urinary incontinence surgery? Int Urogynecol J. 2014 Jan;25(1):41-6. doi: 10.1007/s00192-013-2184-x. Epub 2013 Aug 3.
PubMed 23912506Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.
PubMed 9195314Firoozi F, Gill B, Ingber MS, Moore CK, Rackley RR, Goldman HB, Vasavada SP. Increasing patient preparedness for sacral neuromodulation improves patient reported outcomes despite leaving objective measures of success unchanged. J Urol. 2013 Aug;190(2):594-7. doi: 10.1016/j.juro.2013.03.025. Epub 2013 Mar 14.
PubMed 23499745Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol. 2003 Nov;189(5):1275-82. doi: 10.1067/s0002-9378(03)00598-2.
PubMed 14634553Paraiso MF, Muir TW, Sokol AI. Are midurethral slings the gold standard surgical treatment for primary genuine stress incontinence? J Am Assoc Gynecol Laparosc. 2002 Nov;9(4):405-7. doi: 10.1016/s1074-3804(05)60510-5. No abstract available.
PubMed 12386347McFadden BL, Constantine ML, Hammil SL, Tarr ME, Abed HT, Kenton KS, Sung VW, Rogers RG. Patient recall 6 weeks after surgical consent for midurethral sling using mesh. Int Urogynecol J. 2013 Dec;24(12):2099-104. doi: 10.1007/s00192-013-2136-5. Epub 2013 Jul 2.
PubMed 23818127Dmochowski RR, Blaivas JM, Gormley EA, Juma S, Karram MM, Lightner DJ, Luber KM, Rovner ES, Staskin DR, Winters JC, Appell RA; Female Stress Urinary Incontinence Update Panel of the American Urological Association Education and Research, Inc; Whetter LE. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol. 2010 May;183(5):1906-14. doi: 10.1016/j.juro.2010.02.2369. Epub 2010 Mar 29.
PubMed 20303102Ellett L, Villegas R, Beischer A, Ong N, Maher P. Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):602-11. doi: 10.1016/j.jmig.2014.01.002. Epub 2014 Jan 23.
PubMed 24462856Dawdy K, Bonin K, Russell S, Ryzynski A, Harth T, Townsend C, Liu S, Chu W, Cheung P, Chung H, Morton G, Vesprini D, Loblaw A, Cao X, Szumacher E. Developing and Evaluating Multimedia Patient Education Tools to Better Prepare Prostate-Cancer Patients for Radiotherapy Treatment (Randomized Study). J Cancer Educ. 2018 Jun;33(3):551-556. doi: 10.1007/s13187-016-1091-5.
PubMed 27526692
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Patient-Centered Versus Physician-Centered Counseling Video for Midurethral Slings an RCT
- ClinicalTrials.gov ID
- NCT03198481
- Acronym / sponsor ID
- MUVi / 17-058
- Conditions
- Stress Urinary Incontinence, Satisfaction
- Keywords
- midurethral sling, movie, preparedness, Video Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 26 Jun 2017 (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 decision making process for stress incontinence surgery is complex. A key gap in the literature is how to improve patient preparedness and satisfaction for mid-urethral sling (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap. The specific aims of the proposed research: (1) is to develop two videos to counsel patients who have elected to undergo a MUS surgery. One video will be created from a patient-centered perspective using peers as counselors. The second will employ a traditional counseling approach; (2) To compare the impact of multimedia counseling between women randomized to a patient-centered counseling versus a traditional counseling video. The investigators will recruit patients who present with stress urinary incontinence who elect to undergo a MUS procedure. Women will be randomized during their pre-operative visit to watch the patient-centered or traditional counseling video before they are counseled regarding their upcoming MUS surgery in the usual manner. The investigators anticipate women randomized to a patient centered-video will report higher satisfaction, less decisional regret, greater preparedness, and less anxiety as measured by validated scales. Successful completion will improve understanding of patient's needs and will allow development of improved educational tools readily available to the AUGS community.
Detailed description
Management of Pelvic Floor Disorders (PFDs) is individualized according to a patient's symptomatology and quality of life. Although conservative measures exist, patients may elect for surgical management. The decision making process for surgery is complex. It is well documented that patient's lack understanding prior to their surgical procedures. Preparedness for MUS surgery is related to a patient's comprehension of the purpose, risks, benefits, and complications. Patients who are more prepared prior to surgery have been proven to have greater postoperative satisfaction. Therefore, it is essential to improve patients' preparedness and enhance patients' understanding of realistic expectations of post-operative outcomes.
The investigators long-term goal is to improve patient-centered preparedness and satisfaction when considering surgery. Previous studies by the Preliminary Study of Peer Support Groups and Pelvic Floor Disorders have demonstrated trends in improvement for preparedness and decision conflict with the use of peer focus groups. However, peer support groups are a costly process and there may be many barriers to participation.
A key gap in the literature is how to improve patient preparedness for surgery and improve satisfaction through the use of peer counseling in a manner that is convenient for patients, reproducible and low cost. Technological advances with multimedia may assist in bridging this gap. With ease-of-access to mobile electronic devices, videos are effective tools to prepare patients for surgery. The purpose of this randomized controlled clinical trial is to determine if a patient-centered video improves satisfaction and preparedness compared to a physician-centered video.
The first objective of this research is to develop two videos to counsel patients who have elected to undergo a MUS procedure. One video will be created from a physician-centered approach. The second video will be a patient-centered perspective. The second objective of this research is to compare the impact of video counseling between women randomized to a physician-centered versus a patient-centered video. The central hypothesis is that women randomized to a patient-centered video will report higher scores of satisfaction and preparedness than women randomized to the physician-centered video.
Specifically, our aims for this study are:
- To create two videos to be used to counsel patients who have elected to undergo a MUS procedure. One video will present the risks, benefits and alternatives to MUS surgery by a physician, mimicking traditional counseling prior to surgery. The second video will explain the risks, benefits and alternatives to the MUS surgery utilizing a patient mentor who has undergone the MUS procedure and will describe the patients' perception of the information. The patient-centered video will also include topics that have previously been identified by focus groups as important patient-centered aspects of pre-surgical counseling.
- To compare the impact of video counseling between women randomized to a physician-centered video and a patient-centered video. Hypothesis: Women randomized to a patient centered-video will report higher satisfaction and preparedness as measured by validated scales. They will have higher scores on the Post-operative preparedness questionnaire (PPQ), Preparedness Scale and the Surgical Decision Satisfaction (SDS-PFD) questionnaire; and lower scores on the Decision Regret Scale (DRS-PFD) questionnaire than women randomized to view the physician-centered video prior to undergoing mid-urethral sling surgery.
- To compare a women's decisional conflict post-operatively in women randomized to the physician-centered video and the patient-centered video. Hypothesis: There is a reduction of decisional conflict in women randomized to the patient-centered video.
- To determine if there are differences in anxiety scores in women who watch the patient-centered video versus the physician centered video. Hypothesis: Anxiety scores measured by the State Trait Anxiety Inventory (STAI: Y-6 Item) questionnaire are decreased by a pre-operative patient-centered counseling video.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Centered Counseling Video Group | Active comparator | Behavioral: Patient-Centered Counseling VideoMUS video utilizing a patient mentor. |
| Physician Counseling Video Group | Active comparator | Behavioral: Physician Counseling VideoMUS video by a physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are ≥ 18 years of age
- Planning to undergo a midurethral sling procedure
- Either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with a positive cough stress test or SUI documented on urodynamic testing
- English speaking
Key exclusion criteria (3 listed)
- Those who desire a concomitant POP Surgery
- Inability to speak/understand English
- Prior midurethral sling performed
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 |
|---|---|---|
| Patient-Centered Counseling VideoPatients will watch a patient-centered education video regarding MUS prior to standard pre-operative counseling. | Behavioural | Patient-Centered Counseling Video Group |
| Physician Counseling VideoPatients will watch a physician-centered video regarding MUS prior to standard pre-operative counseling. | Behavioural | Physician Counseling Video Group |
Primary outcome
Patient preparedness
Time frame: Change from baseline at the 6 weeks post-operative visit
The objective is to compare patient preparedness between women in the patient-centered and physician centered video group. The investigators hypothesize that subjects in the patient-centered video group will report higher preparedness pre-operative and 6 weeks post-operative on the Patient Preparedness Questionnaire (PPQ). The investigators will assess the level of pre-operative and post-operative preparedness according to each preparedness question on the Patient Preparedness Questionnaire (PPQ).
2 secondary outcomes
Patient Satisfaction
Time frame: Change from baseline at the 6 weeks post-operative visit
Decision Regret
Time frame: 6 weeks post-operative visit
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 6 Dec 2024.
- Background: PubMed 7277269Reading AE. Psychological preparation for surgery: patient recall of information. J Psychosom Res. 1981;25(1):57-62. doi: 10.1016/0022-3999(81)90084-2. No abstract available.
- Background: PubMed 10249187Pool JJ. Expected and actual knowledge of hospital patients. Patient Couns Health Educ. 1980 3d Quart;2(3):111-7. doi: 10.1016/s0738-3991(80)80051-6. No abstract available.
- Background: PubMed 18060968Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.
- Background: PubMed 23912506Brubaker L, Litman HJ, Rickey L, Dyer KY, Markland AD, Sirls L, Norton P, Casiano E, Paraiso MF, Ghetti C, Rahn DD, Kusek JW. Surgical preparation: are patients "ready" for stress urinary incontinence surgery? Int Urogynecol J. 2014 Jan;25(1):41-6. doi: 10.1007/s00192-013-2184-x. Epub 2013 Aug 3.
- Background: PubMed 9195314Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. doi: 10.1016/s0883-5403(97)90194-7.
- Background: PubMed 23499745Firoozi F, Gill B, Ingber MS, Moore CK, Rackley RR, Goldman HB, Vasavada SP. Increasing patient preparedness for sacral neuromodulation improves patient reported outcomes despite leaving objective measures of success unchanged. J Urol. 2013 Aug;190(2):594-7. doi: 10.1016/j.juro.2013.03.025. Epub 2013 Mar 14.
- Background: PubMed 14634553Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC. Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol. 2003 Nov;189(5):1275-82. doi: 10.1067/s0002-9378(03)00598-2.
- Background: PubMed 12386347Paraiso MF, Muir TW, Sokol AI. Are midurethral slings the gold standard surgical treatment for primary genuine stress incontinence? J Am Assoc Gynecol Laparosc. 2002 Nov;9(4):405-7. doi: 10.1016/s1074-3804(05)60510-5. No abstract available.
- Background: PubMed 23818127McFadden BL, Constantine ML, Hammil SL, Tarr ME, Abed HT, Kenton KS, Sung VW, Rogers RG. Patient recall 6 weeks after surgical consent for midurethral sling using mesh. Int Urogynecol J. 2013 Dec;24(12):2099-104. doi: 10.1007/s00192-013-2136-5. Epub 2013 Jul 2.
- Background: PubMed 20303102Dmochowski RR, Blaivas JM, Gormley EA, Juma S, Karram MM, Lightner DJ, Luber KM, Rovner ES, Staskin DR, Winters JC, Appell RA; Female Stress Urinary Incontinence Update Panel of the American Urological Association Education and Research, Inc; Whetter LE. Update of AUA guideline on the surgical management of female stress urinary incontinence. J Urol. 2010 May;183(5):1906-14. doi: 10.1016/j.juro.2010.02.2369. Epub 2010 Mar 29.
- Background: PubMed 24462856Ellett L, Villegas R, Beischer A, Ong N, Maher P. Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):602-11. doi: 10.1016/j.jmig.2014.01.002. Epub 2014 Jan 23.
- Background: PubMed 27526692Dawdy K, Bonin K, Russell S, Ryzynski A, Harth T, Townsend C, Liu S, Chu W, Cheung P, Chung H, Morton G, Vesprini D, Loblaw A, Cao X, Szumacher E. Developing and Evaluating Multimedia Patient Education Tools to Better Prepare Prostate-Cancer Patients for Radiotherapy Treatment (Randomized Study). J Cancer Educ. 2018 Jun;33(3):551-556. doi: 10.1007/s13187-016-1091-5.
- 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.
Yuko M Komesu, MD principal investigator
University of New Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centered Counseling Video and Physician Counseling Video in people with Stress Urinary Incontinence and Satisfaction, run by University of New Mexico at 2 sites 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 4 inclusion and 3 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 preparedness (time frame: Change from baseline at the 6 weeks post-operative visit). 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 NCT03198481, which also lists 12 linked publications.
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 6 Dec 2024.