Clinical trial: NCT03063125
Section: Alternatives
Subsections: Alternatives

Participation in this study is voluntary. Deciding not to participate will have no effect on the care or services you receive at the University of Kansas Medical Center.
Clinical trial: NCT03063125
Section: Confidentiality
Subsections: Confidentiality And Privacy Authorization

The researchers will protect your information, as required by law. Absolute confidentiality cannot be Page 3 of 4 guaranteed because persons outside the study team may need to look at your study records. The researchers may publish the results of the study. If they do, they will only discuss group results. Your name will not be used in any publication or presentation about the study. Your health information is protected by a federal privacy law called HIPAA. By signing this consent form, you are giving permission for KUMC to use and share your health information. If you decide not to sign the form, you cannot be in the study.  
The researchers will only use and share information that is needed for the study. To do the study, they will collect health information from the study activities and from your medical record. You may be identified by information such as name, address, phone, date of birth, social security number, or other identifiers. Your health information will be used at KU Medical Center by Dr. Jeffery Holzbeierlein, members of the research team, the KUMC Research Institute, the KUMC Human Subjects Committee and other committees and offices that review and monitor research studies. Study records might be reviewed by government officials who oversee research, if a regulatory review takes place. Your permission to use and share your health information remains in effect until the study is complete and the results are analyzed. After that time, researchers will remove personal information from study records.  
All study information that is sent outside KU Medical Center will have my name and other identifying characteristics removed, so that my identity will not be known. Because identifiers will be removed, my health information will not be re-disclosed by outside persons or groups and will not lose its federal privacy protection. Your permission to use and share your health information remains in effect until the study is complete and the results are analyzed. After that time, researchers will remove personal information from study records.
Clinical trial: NCT03063125
Section: Participant's Rights
Subsections: Subject Rights And Withdrawal From The Study

You may stop being in the study at any time. Your decision to stop will not prevent you from getting treatment or services at KUMC. The entire study may be discontinued for any reason without your consent by the investigator conducting the study. You have the right to cancel your permission for researchers to use your health information. If you want to cancel your permission, please write to Dr. Jeffery Holzbeierlein. The mailing address is Dr. Jeffery Holzbeierlein, University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160. If you cancel permission to use your health information, you will be withdrawn from the study. The research team will stop collecting any additional information about you. The research team may use and share information that was gathered before they received your cancellation.
Clinical trial: NCT03063125
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks

There are minimal risks to participating. Blood draw may result in pain, infection, bruising, and fainting. There may be other risks of the study that are not yet known. If these are discovered, you will be notified.
Clinical trial: NCT03063125
Section: Procedures
Subsections: Participation/Procedures

If you choose to participate in this study, your testosterone and related hormone levels will be obtained through blood draws at several instances around the time of your bladder surgery. Laboratory draws will occur a total of 4 times: before surgery during your pre-operative clinic appointment, two days after surgery while in the hospital, at your first post-operative visit (2-3 weeks after discharge), and at your three-month follow up clinic appointment. All blood draws will occur when you are having standard of care labs for routine care, in order to avoid extra needle sticks. An additional 5 mL (1 teaspoon) of blood will be drawn at each time point. Your laboratory results will be shared with you. If you are found to have low testosterone levels, you will be provided follow up with a urologist who is fellowship trained in andrology. Further discussion regarding testosterone replacement and follow up of testosterone levels can be discussed at that follow up visit after recovery from surgery.