About

The goal of the PROUD Study is to compare two different online and phone-based health education or exercise coaching programs aimed at improving urinary symptoms and functioning among men with an enlarged prostate or benign prostatic hyperplasia (BPH).

Who Is Eligible?

Patients are eligible to participate if:

  • You are 60 years old or older
  • You have been diagnosed and treated for an enlarged prostate or Benign Prostatic Hyperplasia (BPH) or you have urinary symptoms that might be due to this condition
  • You are able to walk 1/4 mile without sitting, leaning, or the help of another person
  • You have an iOS or Android smartphone capable of installing the Polar Beat app
  • You are fluent in English
  • You are willing to travel to the UCSF Mission Bay campus for 2 in-person assessments

Patients are not eligible if:

  • You have had prostate or bladder surgery
  • You use a permanent or temporary urinary catheter
  • You have received an overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation)
  • You have urethral strictures
  • You have prostate cancer treated with surgery or radiation (active surveillance okay), bladder cancer, other lower urinary tract cancer
  • You have received pelvic radiation
  • You have a neurogenic bladder or neurologic conditions that can cause lower urinary tract dysfunction (e.g., Parkinson’s disease, multiple sclerosis, other progressive neurological disease)
  • You have a severe visual or hearing impairment that would limit your ability to see or hear the coaches directions on your computer, tablet, or phone
  • You are participating in another research study

What will happen if I take part in this study?

Phone/Zoom Screener: 15-30 Minutes

We will describe the study to you and ask you a series of questions to determine if this study is right for you. This will take about 15 minutes, over the phone or Zoom. If you are eligible for the study, the following things will happen:

Prior to your onsite baseline study visit (approximately 2.5 hours):

  • Complete clinical labs at a local LabCorp (near your home or work) (1 hour) (select individuals).
  • Complete questionnaires on your lifestyle habits, symptoms, and mobility at home (1.5 hours).
  • Muscle mass: you will have your muscle mass accurately measured using a “Deuterated (D3)-Creatine Dilution” test. This test measures how much labeled creatine is retained or excreted in your urine based on the body’s amount of muscle. The test involves taking a pill that contains creatine (a muscle-related substance in many protein foods) that has been labeled with a way to measure it in your urine. After taking the pill at home, you will be asked to provide a fasting urine sample during the baseline visit. The “Deuterated (D3)-Creatine Dilution” test is safe and has been used for testing in thousands of infants, children, and older adults. 

At your onsite baseline study visit at UCSF Mission Bay campus (approximately 5.5 hours):

  • Blood draw and urine collection.
  • Cognitive function testing: several memory and attention tests will be administered by study staff.
  • Urinary function measure #1: Urinate into a uroflowmeter device, which is a specialized urinal that measures the amount of urine you void over time.
  • Urinary function measure #2: Complete a post-void residual test, which uses an ultrasound probe on your stomach to measure the amount of urine left in your bladder after you have completed voiding.
  • Physical assessment: resting blood pressure, resting heart rate, height, weight, waist circumference.
  • Physical function testing: YMCA step test, 400m walking speed, Short Physical Performance Battery, grip strength, leg extension strength at UCSF Human Performance Center/UCSF Bakar gym.

After completing your on-site study visit, we will confirm whether you are eligible to continue in the study. If you are eligible, you will complete the remaining study procedures:

  • Wear an accelerometer for 7 days. This is a device worn like a watch around your wrist or belt around your hip.
  • Complete a frequency-volume chart each day for 3 days. This involves measuring how much urine you produce using a provided measurement device for 3 days. This will take approximately 30 minutes/day.

​At week 4 (at-home only; approximately 30 minutes):

  • Questionnaires on your urinary symptoms and physical activity only

At week 8 (at-home only; approximately 30 minutes):

  • Questionnaires on your urinary symptoms only

At week 12 (approximately 5.5 hours for onsite study visit; total 8 hours):

  • Same procedures as done at the on-site baseline visit.
  • Wear an accelerometer for 7 days.

At week 24 (at-home only; approximately 2 hours for health education group; 2.5 for exercise coaching group): 

  • Questionnaires on your lifestyle habits, symptoms, and mobility (1.5 hours)
  • Wear an accelerometer for 7 days.
  • Complete a phone interview about your study experience (exercise coaching group only)

The total time anticipated for the entire study is approximately 21-22 hours.

How long will I be in this study?

The online and phone-based health education or exercise coaching programs take 12 weeks to complete and participation in the study will take about 7 months (this includes questionnaires at baseline, week 12, and week 24).

Will I be compensated?

In return for your time and effort, you will be paid up to $150 in gift cards for taking part in this study. You will receive $50 worth of gift cards for the completion of the baseline assessments, $50 worth of gift cards for completing the assessments at 12 weeks, and $50 worth of gift cards for completing the assessments at 24 weeks. This payment will be electronically delivered. You will also receive free parking and meals during on-site visits.

How will information about me be kept private?

We will do our best to make sure that the personal information gathered for this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

Authorized representatives from the following organizations may review your research data for the purpose of monitoring or managing the conduct of this study: 

  • Representatives of the National Institutes of Health
  • Representatives of the University of California
  • Representatives of the Office of Human Research Protections (OHRP)
  • Representatives of the Department of Veterans Affairs
  • The Northern California Institute for Research and Education

Participation in research may involve a loss of privacy, but information about you will be handled as confidentially as possible. A medical record will be created because of your participation in this study. Your consent form and some of your research test results will be included in this record. Therefore, your other health care providers may see your test results and become aware of your participation. Hospital regulations require that all health care providers treat information in medical records confidentially.

How many people will take part in this study?

A total of 68 people with urinary symptoms due to an enlarged prostate or benign prostatic hyperplasia (BPH) will take part in this study.

What are my rights if I take part in this study?

Taking part in this study is completely your choice.

You may choose either to take part in the study or not take part in the study. If you decide to take part in the study, you may leave the study at any time, for any reason.

Who are the study investigators?

Who is this study funded by?

This study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases, in collaboration with the San Francisco Veterans Affairs, University of California, San Francisco, and the Northern California Institution for Research and Education.