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Behavioral Intervention

Exercise for Enlarged Prostate (PROUD Trial)

N/A

Recruiting

Led By Scott R. Bauer, MD, ScM

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 60 years or older

Male sex at birth

Must not have

History of urethral strictures

Major surgery <3 months before screening or scheduled in the subsequent 7 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18-24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of a 12-week exercise program on older men with urinary problems caused by an enlarged prostate. The men will be randomly assigned to either the exercise program or a health education

Who is the study for?

Men aged 60+ with moderate-to-severe urinary symptoms due to enlarged prostate, not very active physically, can walk 400m unaided (cane ok), and have a smartphone. They shouldn't be on certain bladder medications or have had recent changes in prostate meds, nor should they have a history of specific urologic surgeries or cancers.

What is being tested?

The study is testing if a remote exercise program helps older men with urinary issues from an enlarged prostate better than just receiving health education. Participants will either do the exercises or get calls and newsletters for comparison.

What are the potential side effects?

Since this trial involves exercise as an intervention, potential side effects may include typical exercise-related issues such as muscle soreness, fatigue, or injury. Health education control has no physical side effects but may lack the benefits of active intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I was assigned male at birth.

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I have had moderate to severe urinary symptoms in the past month.

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I have been diagnosed with or treated for prostate gland enlargement.

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I can walk 400m on my own but may use a straight cane.

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I can speak English and fill out forms in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had narrowings in my urethra before.

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I haven't had major surgery in the last 3 months and don't plan any in the next 7 months.

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I have a condition like Parkinson's or MS affecting my bladder control.

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I do not have severe kidney or heart issues, or a pacemaker without doctor's approval.

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My blood pressure is not within the normal range.

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I haven't changed medications that could affect urinary symptoms in the last month and won't change them for 7 months.

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I have had surgery for an enlarged prostate.

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I have had 3 or more bladder or prostate infections in the last year.

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My doctor estimates I have less than 12 months to live due to my illness.

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I have had a procedure for overactive bladder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability: proportion satisfied with exercise intervention

Change in International Prostate Symptom Score

Change in maximum urinary flow rate

+3 more

Secondary study objectives

Acceptability: proportion who would recommend exercise intervention

Fidelity: number of exercise sessions completed for aerobic, resistance, and balance/flexibility exercise

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise ArmExperimental Treatment1 Intervention

Participants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program.

Group II: Control ArmActive Control1 Intervention

Participants in this study arm will receive a remote health education program which consists of twice-monthly "Successful Aging" newsletters and phone calls to reinforce and discuss topics in each newsletter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

0 / 16Eligibility criteria met