Actively Recruiting
PRescription Exercise for Older Men With Urinary Disease
Led by University of California, San Francisco · Updated on 2025-03-17
68
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
U
University of California, Berkeley
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRescription Exercise for Older Men With Urinary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Male sex at birth
- Moderate-to-severe lower urinary tract symptoms over the past month (International Prostate Symptom Score ≥12)
- Clinical diagnosis of LUTS/BPH shown by current or prior BPH medication use or untreated LUTS/BPH with maximum urinary flow rate ≤12 ml/sec
- Physically inactive: no more than 1 day per week and 60 minutes per session of regular aerobic or resistance exercise in the past year
- Able to walk 400 meters without sitting, leaning, or help (use of straight cane allowed)
- Able to speak and complete questionnaires in English
- Own an iOS or Android smartphone capable of installing the Polar Beat app
You will not qualify if you...
- Use of overactive bladder medications within 3 months before screening
- Changes to BPH medications within 1 month before screening (6 months for 5-alpha-reductase inhibitors) or unwillingness to keep medication stable for 7 months
- Changes to other medications or supplements affecting LUTS within 1 month before screening or unwillingness to keep stable for 7 months unless clinically necessary
- History of BPH procedure or surgery
- History of overactive bladder procedures (e.g., Botox, neuromodulation)
- History of prostate, bladder, or lower urinary tract cancers or active non-urologic cancer treatments
- History of urethral strictures
- Neurologic conditions causing lower urinary tract dysfunction (e.g., Parkinson's, multiple sclerosis)
- Recurrent bladder or prostate infections (3 or more in past 12 months)
- Severe or end-stage kidney disease, transplants, severe heart conditions, pacemaker or defibrillator without clearance
- Major heart or vascular events or non-elective hospitalization within 6 months before screening without clearance
- Recent bladder or prostate infections or major surgery within specified timeframes without clearance
- Terminal illness with life expectancy under 12 months
- Plans to be away from study area for more than 28 consecutive days in 7 months
- Participation in other behavioral LUTS interventions within 1 month before screening
- Symptoms of serious cardiovascular or metabolic conditions without clearance
- Very low urinary flow rates or high post-void residual volume during screening
- Uncontrolled high or low blood pressure during baseline assessments
- Severe lab abnormalities without clearance
- Other medical, psychiatric, or behavioral issues that may interfere with participation
- Use of permanent or temporary urinary catheter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Actively Recruiting
2
UCSF Health - Mission Bay Campus
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
S
Scott R. Bauer, MD, ScM
CONTACT
S
Stacey Kenfield, ScD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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