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Behavioral Intervention

Exercise Arm for Lower Urinary Tract Symptoms (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18-24 months

Awards & highlights

PROUD Trial 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.Check my eligibility

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.See study design

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.

PROUD Trial 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.

PROUD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability: proportion satisfied with exercise intervention

Change in International Prostate Symptom Score

Change in maximum urinary flow rate

+3 more

Secondary outcome measures

Acceptability: proportion who would recommend exercise intervention

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

PROUD 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

~760

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,487 Total Patients Enrolled

1 Trials studying Lower Urinary Tract Symptoms

31 Patients Enrolled for Lower Urinary Tract Symptoms

University of California, BerkeleyOTHER

181 Previous Clinical Trials

721,088 Total Patients Enrolled

University of California, San DiegoOTHER

1,121 Previous Clinical Trials

1,520,856 Total Patients Enrolled

3 Trials studying Lower Urinary Tract Symptoms

5,231 Patients Enrolled for Lower Urinary Tract Symptoms

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being actively sought for this ongoing research study?

"As per the information available on clinicaltrials.gov, this particular study is not presently seeking participants. It was initially posted on January 31st, 2024 and was last updated on January 24th, 2024. However, it's important to note that there are currently 164 other ongoing clinical trials actively enrolling participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRescription Exercise for Older Men With Urinary Disease

2024. "PRescription Exercise for Older Men With Urinary Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225479.

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