Informed Consent Form
A copy of the form will be sent to your e-mail inbox after signing.
This form describes in detail how the study works and what your role is.
Your signature means you understand and you agree to participate.
Study Title:
Use of a validated mobile application for evaluating progression and management of lower urinary tract symptoms
Protocol No.:
WCG IRB Protocol #20226657
Sponsor:
Soundable Health, Inc.
Investigator:
Bilal Chughtai M.D. 425 East 61st, 12th floor New York, New York 10065 United States
Study related phone number(s):
649-962-4811
649-962-0140
bic9008@med.cornell.edu
Taking part in this research is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.
If you have any questions, concerns, or complaints or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.
Introduction-Summary of Key Information
You are receiving this Informed Consent Form because you have expressed interest in participating in this voluntary research study.
This study aims to advance understanding of progression and management of lower urinary tract symptoms through patient-generated real-world data. There may not be a direct benefit to you.
This study comprises both prospective collection and retrospective collection of data. You can opt in/out of each. The duration of your study participation will be determined based on your decision to opt into the prospective collection only or the retrospective collection only or both.
Participation is voluntary. You can decline to participate in the study, leave the study or stop sharing your data at any time.
The study staff will work to keep your data confidential and secure.
Risks of participation include the possible loss of confidentiality of your information.
Your alternative is to not to participate in this study.
Your signature means you understand and agree to participate and then, you will receive a signed copy of this consent. If you do not take part in the study, you will not lose any benefits or medical care to which you are otherwise entitled. You do not have to sign this consent, but if you do not, you will not be able to participate in this study.
Background and Purpose
You are invited to participate in this study, which is designed to advance understanding of progression and management of lower urinary tract symptoms(LUTS) in men. This study aims to look at factors that may be associated with the progression of LUTS and establish a comprehensive understanding of current LUTS management options, which may include watchful waiting, lifestyle modifications, medication, or surgery. The study will collect information about health by using questionnaires and by measuring urinary functions through this mobile application. The knowledge gained from this research may help to inform other men who are concerned with LUTS and contribute to building high quality of evidence to evaluate LUTS management options.
What happens if I decide to join this Study?
Who can participate in this study?
To participate in this study, you must:
Be at least 18 years old male
Be comfortable communicating in written and spoken English
Have installed a mobile application with proudP® technology on one's own phone
Be willing and able to provide informed consent to participate in the study
Be willing and able to follow instructions given in the application
If you do not meet these requirements, you will not be eligible to participate.
What is the study procedure?
You can participate in this study simply by using this mobile application on your smartphone.
You will be asked to create an account with the mobile application and then sign this consent form to enroll into the study. Once you’ve signed the consent form, you will be given introduction to the study procedure. You will be asked to establish your current health profile relating to LUTS including medical history, social history, medications/surgical history, family history and lab results.
Periodically, you will be asked to complete questionnaires and measure your urinary function. This will help the researchers to understand the trend of LUTS over time.
You will be asked to record your urination sound in your bathroom to get measurements of your urinary function. The proudP® technology (sound analytics technology developed by the Sponsor) embedded in this mobile application will analyze your urination sound and convert the recording into quantitative measurements.
How many will participate in this study?
This study is targeting to enroll 100 participants. The recruitment will stop when approximately 100 participants provide consent to collection.
What are the benefits of participating in this study?
There might not be a direct benefit to you, but by partaking in this study, it is anticipated that your data will help researchers in advancing the understanding of the progression of LUTS in men and help evaluate management options of LUTS. By using this mobile application as a self-monitoring tool at home for urinary health, you may benefit from becoming more aware of your health status.
The participation is solely voluntary. This will contribute to the future of the adult male, who is concerned with LUTS or not, living a better quality of life by giving comprehensive data to evaluate management options of lower urinary tract symptoms. This study is a non-interventional study that will not mandate a specific assessment schedule, and the participation is solely voluntary. The mobile application with proudP® technology may suggest a guide of assessment scheduling and notify the participant who decides to opt in the prospective data collection.
Are there any alternatives to participating?
Instead of participating in this study, you may choose not to participate in this study. If you choose to participate, and start being in the study, you can always withdraw your consent.
Voluntary participation and consent withdrawal
Your participation in this research is voluntary. The decision not to participate in the study does no harm. Additionally, you can withdraw anytime even after the consent to participate and you would not suffer a disadvantage or damage due to stopping your participation.
Data Collection
As part of this study, you will be asked to provide data associated with LUTS using this mobile application.
The data provision will be solely voluntary.
Contact information, such as your name, e-mail address and phone number
Demographic data, such as your date of birth, race, height and weight
Measurements of your urinary function by recording your urination sound in your bathroom
Uroflowmetry measurements: voided volume, maximum flow rate, average flow rate, voiding time, and flow curve
Voiding diary measurements: daily record of urination behaviors. To assess nocturia, you may be notified from the mobile application to enter the wake up time of the day as well as sleep time of the day or may be asked to mark which voids are nighttime voids. You may report fluid intakes by entering the amount of fluid.
Questionnaires to learn about your urinary function, sexual function, sleep problems, and quality of life.
Social history; family history; medical history; medications history including experience of adverse drug effect; surgical history; and biomarkers and laboratory measurements such as prostate specific antigen (PSA), prostate size volume (PSV), post-void residual (PVR), and urodynamic results if available.
The natural information collected from this study will be significant in building up the high quality of data. It is available to evaluate management options of LUTS, giving evidence-based data for those management procedures to adult male who are concerned with LUTS.
Retrospective and prospective data collection
Data related to LUTS will be collected prospectively and retrospectively using this mobile application. You may choose to participate in one or both of these two data collections.
Retrospective data: If you have utilized this mobile application before, you are eligible for the retrospective data collection. The retrospective collection refers to the collection of any data that you’ve recorded using this mobile application up to the date of consent to this study.
Prospective data: The prospective collection refers to the collection of data after we obtain your consent. If you consent to the prospective collection, you will record data by utilizing this mobile application for 24 months. You will not be mandated to follow any assessment schedule, but you may be recommended.
For overall study, data will be utilized if it was recorded from January 1, 2020 to December 31, 2027 via the mobile application. Your duration of study participation will be determined based on your decision to opt in to the prospective collection only or the retrospective collection only or both.
If you consent to the participation only in the prospective collection:
Your duration of study participation will be 24 months. The Investigator will utilize your data collected over 24 months after you consented.
If you consent to the participation only in the retrospective collection:
Your duration of study participation will be 0 days. The Investigator will utilize the existing data that you had already accumulated up to the date of consent.
If you consent to the participation in both:
Your duration of study participation will be 24 months. The Investigator will utilize both the data collected over 24 months after you consented and the existing data that you had already accumulated up to the date of consent.
If this study is still ongoing following 24 months after the initial consent, you may be asked to provide consent for extension or renewal. We plan to gather data related to LUTS using this mobile application prospectively and retrospectively. You may choose to participate in one or both of these two collections.
How will my study data be managed?
Your study data collected throughout the study will be kept secure and confidential. Your study data will be stored in a data management system, which will be reviewed only for research.
Your private information and your medical record will be shared with individuals and organizations that conduct or watch over this research, including:
The research sponsor
People who work with the research sponsor
Government agencies, such as the Food and Drug Administration (FDA)
Measurements of your urinary function by recording your urination sound in your bathroom
Your contact information and other directly identifying information will only be limited to the study staff who needs access in order to support and conduct the study.
By signing this consent form, you agree that study staff may contact you directly by telephone or email about the study or your participation, during or after the study. For example, we may need to discuss your study engagement, clarify your questionnaire responses, address technical issues you may experience, follow-up about your health outcomes, investigate suspected adverse events you may have experienced, or other findings that may affect your decision to remain in the study.
Your study data may be converted to a de-identified dataset where your contact information and other directly identifying information will be removed from the data set.
The de-identified dataset may be used by the Sponsor or third parties for the following purposes:
To analyze the study data and publish the study results
To design or improve future studies
For development, design, improvement, production, publication, and/or support of health and wellness products, technologies, processes, and services, including to develop a better understanding of and/or helping to develop new ways to identify, prevent or otherwise address certain health conditions or wellness issues, including algorithm development for these purposes
The third parties will only have access to the aggregate level of de-identified dataset, limiting access to raw de-identified dataset. The third parties may include academics, healthcare providers, pharmaceutical companies, medical device companies, supplement companies or companies that are interested in developing services, products or technologies associated with advancing the management of LUTS.
Data collected in this research might be de-identified and used for future research or distributed to another investigator for future research without your consent.
The data will be retained for 3 years (stored encrypted) after the completion of the study is approved for the study.
If you have any questions on your privacy rights, email us at privacy@soundable.health
Research Outputs
Outputs of this study will include journal articles, conference publications, presentations, white papers, and data reports.
The Investigator or the Sponsor may publish, present, or share these outputs to/with general public, academic associates in medicine, or third parties.
Though the Investigator collects data from individual subjects, mostly the collected data will be integrated and processed in statistics when published, presented, or shared. It will be ensured that all the outputs published, presented, or shared will be only in a form that is not possible to identify you.
Risks, Adverse effects and Discomforts
There would be no expected harm or hazard to the participating subjects. Risks are, at most, minimal because the study is limited to the review of data that you generate. No additional physical or economic harm is expected as a result of the participation of the study.
There may be general risks associated with the use of the mobile application. Some of these risks will still apply when you decide not to participate in the study and when you are using your smartphone for your personal uses.
Eyesight: Since this mobile application is smartphone-based, your eyesight may be affected by having close contact with the mobile devices. However, this is an existing and on-going potential risk for all smartphone users.
Dropping the smartphone: Measurements of quantitative indicators of urinary functions using proudP® technology entails recording the urination sound into the water-filled toilet bowl. The phone may be at the risk of being dropped into the toilet water. This risk is mitigated by providing participants with instructions on how to use the mobile application - the instruction specifies that participants place the smartphone on a water tank or vanity top, not holding the smartphone in their hands.
Fatigue of completing questionnaires: You may become bored or fatigued from completing the questionnaires multiple times. It is noted that efforts were made to create a private and safe environment to perform the questionnaires with convenience. You may discontinue participation at any time.
Social risk of data breach: The potential risk or discomforts with respect to societal harms in this study would be the social risk of data breach. To address the privacy and confidentiality concerns, all data collected will be encrypted in transit and at rest. Your answers will only be identifiable to the research team and the access to that information will be restricted to the research team only.
If the study results in any harm, the research team will provide compensation for the harm based on the victims’ compensation protocol. You do not give up any legal rights by signing this consent form.
The Investigator will monitor and review the study progress and the accuracy and security of the emerging data. If you have any adverse effects, harm, or discomfort email us at support@soundable.health
Financial Considerations
Your participation in this study through the mobile application is solely voluntary.
You will not be charged to participate in this Study.
You will not be compensated for taking part in this Study. You will be expected to be responsible to pay for the standard phone calling, text messaging and data usage as per your phone network plan.
Only in the case that the recommended assessment schedule includes both recording quantitative indicators with proudP® technology and answering PRO questionnaires more than three times over three months, subjects will be rewarded for their time and efforts to complete the recommended assessments. The reward will be paid by a 100 USD amount of e-gift card via the email address (that the participant entered into the mobile app to enroll in this study) within 10 business days after the participant completes the recommended assessment.
Your data will contribute to the advancement of LUTS management in men by giving comprehensive data points from the real-world setting about different management options.
Financial Disclosure
Dr. Chughtai has received private equity (stock, options, or other ownership interest) from the sponsor in the past 12 months. Please feel free to ask any further questions you might have about this matter.
More questions?
If you have questions, concerns, or complaints, or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.
This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com
if:
You have questions, concerns, or complaints that are not being answered by the research team.
You are not getting answers from the research team.
You cannot reach the research team.
You want to talk to someone else about the research.
You have questions about your rights as a research subject.
For questions about the study, any problems, unexpected discomforts, using this mobile application, please contact the research team below:
Ahnyung Lee, Study Support 858-205-7676 (Call and text available. Please refer to this study.) support@soundable.health
CONSENT FOR RESEARCH STUDY
I have been informed about this study’s purpose, procedures, possible benefits and risks.
I read the explanatory note on the consent, thoroughly understood the contents, and am conscious of the fact that the study is performed for the research purpose.
My decision of participation is voluntary and I understand that I can reject or withdraw my continuity of participation anytime due to personal reasons during the study and I would not suffer any disadvantage.
I can always ask the Investigator or the Study Support if I have any questions regarding the study. Hereupon, I agree to participate in the study according to my voluntary intention.