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PRescription Exercise for Older Men With Urinary Disease | Clinical Trials | Clareo Health

RECRUITINGNA

PRescription Exercise for Older Men With Urinary Disease

PRescription Exercise for Older Men With Urinary Disease (PROUD) Pilot Study

NCT06225479•University of California, San Francisco

Summary

This is a single-center pilot randomized controlled trial among 68 physically "inactive" older men with lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (LUTS/BPH) assessing a 12-week remote exercise intervention versus health education control.

Detailed Description

This study will provide valuable insights into the feasibility of an individualized, remotely-monitored, and home-based exercise intervention as well as the effect of this intervention on lower urinary tract symptom (LUTS) severity and mechanistic measures (physical function, lower urinary tract function, frailty-related mechanistic biomarkers) in a diverse group of older men with LUTS attributed to benign prostatic hyperplasia (BPH). The potential public health benefit to society in this study could be large, as the investigators are targeting a common condition in older men (one in three older men develop LUTS in their lifetime).

Eligibility

Age

60 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Age 60 years or older.
•2. Male sex at birth.
•3. Moderate-to-severe LUTS over the past month (defined as International Prostate Symptom Score \[IPSS\] \>=12).
•4. A clinical diagnosis of LUTS/BPH as demonstrated by a current or prior BPH medication prescription (alpha-blocker, 5alpha-reductase inhibitor, daily phosphodiesterase type 5 inhibitor) OR untreated LUTS/BPH and a maximum urinary flow rate \<=12 ml/sec.
•5. Physically inactive as defined in the Molecular Transducers of Physical Activity Consortium (MoTrPAC): no more than 1 day per week, lasting no more than 60 minutes, of regular endurance/aerobic exercise \[e.g., brisk walking, jogging, running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate (HR), rapid breathing, and/or sweating\] or resistance exercise \[resulting in muscular fatigue\] in the past year). Leisure walkers are eligible unless they meet the HR, breathing, and sweating criteria.
•6. Able to walk 400m without sitting, leaning, or the help of another person (observed during exercise testing) to ensure safety while exercising with remote monitoring. Use of a straight cane is allowed.
•7. Able to speak and complete questionnaires in English.
•8. Have an iOS or Android smartphone capable of installing the Polar Beat app.

Exclusion Criteria

•1. Prescribed overactive bladder medications (e.g., anti-muscarinics, beta-3-adrenergic agonists) \<3 months before screening.
•2. Initiation, dose escalation, or weaning of BPH medications \<1 month before screening (\<6 months for 5-alpha-reductase inhibitors). Participants' must also be willing to not start, stop, or change their BPH medications for the subsequent 7 months (the entire study period).
•3. Initiation, dose escalation, or weaning of other pharmacologic agents or dietary supplements that might affect LUTS (e.g., saw palmetto, testosterone, diuretics, glucose-lowering agents) \<1 month before screening. Participants' must also be willing to not start, stop, or change these medications for the subsequent 7 months (the entire study period) unless deemed necessary by their clinician.
•4. History of BPH procedure or surgery.
•5. History of overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation).
•6. History of prostate cancer (treated with surgery or radiation), bladder cancer, other lower urinary tract cancer, pelvic radiation, or active non-urologic cancer treatments.
•7. History of urethral strictures.
•8. History of neurogenic bladder or neurologic conditions causing lower urinary tract dysfunction (e.g., Parkinson's disease, multiple sclerosis, other progressive neurological disease).
•9. History of recurrent bladder or prostate infections (3 or more infections in the previous 12 months before screening).
•10. History of severe or end-stage chronic kidney disease disease, kidney transplant, heart transplant, congenital heart disease, severe heart failure (defined as current New York Heart Association (NYHA) Class III or IV), valvular heart disease, diabetic coma, or the presence of a pacemaker or implantable cardiac defibrillator without clinician clearance.
+13 more criteria

Locations (2)

San Francisco VA Medical Center

San Francisco, California, United States

UCSF Health - Mission Bay Campus

San Francisco, California, United States

Key Dates

Start Date

January 3, 2024

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2026

Last Updated

March 17, 2025

Enrollment

ESTIMATED participants

Conditions

Lower Urinary Tract SymptomsBenign Prostatic Hyperplasia

Interventions

Exercise

BEHAVIORAL

Calls and Newsletter

OTHER

Contacts

Scott R. Bauer, MD, ScM

CONTACT

415-221-4810 Scott.Bauer@ucsf.edu

Stacey Kenfield, ScD

CONTACT

415.476.5392 Stacey.Kenfield@ucsf.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PRescription Exercise for Older Men With Urinary Disease

Inclusion Criteria

Exclusion Criteria

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