ClinicalTrials.gg
CompletedNCT06225479PROUDUpdated Oct 14, 2026

PRescription Exercise for Older Men With Urinary Disease

An interventional study of Exercise and Calls and Newsletter in Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to male participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Updated Oct 14, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
60 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 111 studies in Lower Urinary Tract Symptoms with a site in United States — 15 open to participants now, 25 under way, 1 of them phase 3. Lower Urinary Tract Symptoms · United States.

Enrollment
44th of 85
68 · median 72
Started
2024
with 4 others
No phase
45 of 111
6 open now
Registered
94th of 111
by date

Among the 111 studies in Lower Urinary Tract Symptoms with a site in United States, this one is the 44th largest by enrollment of the 85 interventional ones that give a count, is one of 5 that started in 2024, is one of 45 with no phase, and was the 94th registered.

Lower Urinary Tract Symptoms

417 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

Browse Lower Urinary Tract Symptoms studies →

Open to participants now

15 of the 111 studies in Lower Urinary Tract Symptoms with a site in United States are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 59 Lower Urinary Tract Symptoms studies recruiting now, 39 (66%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.

This study: 60 Years and older · male · no healthy volunteers.

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02

Study 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.

Read the 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).

03

Conditions studied

  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia

Keywords

  • physical fitness
  • endurance training
  • resistance training
  • prostatism
  • male urogenital diseases
  • urinary bladder outlet obstruction
  • skeletal muscle
  • mitochondria
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (NYHA) Class III or IV), valvular heart disease, diabetic coma, or the presence of a pacemaker or implantable cardiac defibrillator without clinician clearance.
  11. Heart attack or myocardial infarction, heart surgery, cardiac catheterization, stroke, , brain hemorrhage, bleeding brain aneurysm, blood clot in leg or lungs, symptomatic hypoglycemia or hyperglycemia, hip fracture, or non-elective hospitalization \<6 months before screening. If conditions occurred 6 to \<12 months before screening, can participate with clinician clearance.
  12. Bladder or prostate infection \<1 months before screening. If infection occurred between 1 to \<3 months before screening, can participate with clinician clearance.
  13. Major surgery \<3 months before screening or scheduled in the subsequent 7 months.
  14. Terminal illness diagnosis with estimated \<12 months.
  15. Plan to leave the study area for >28 consecutive days during the subsequent 7 months.
  16. Participation in formal behavioral LUTS interventions (e.g., pelvic floor physiotherapy) \<1 month before screening.
  17. Symptoms of possible coronary artery disease, heart failure, arrythmia, stroke, carotid artery stenosis, valvular heart disease, blood clot in lungs, poorly controlled diabetes, peripheral vascular disease, or bladder or prostate infection without clinician clearance.
  18. Maximum urinary flow rate \<=4 ml/sec OR volume voided during free flow \<120ml during screening or the baseline visit.
  19. Post-void residual >=450ml measured by ultrasound during screening or the baseline visit.
  20. Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg) or hypotension (systolic blood pressure\<100mmHg) measured during baseline visit anthropometric assessments.
  21. Severe abnormalities on standard clinical labs measured prior to the baseline visit, without clinician clearance, including (>10%) and urinary albumin: creatinine ratio (>300 mg/g).
  22. Other medical, psychiatric, or behavioral factors or participation in other research studies that, based on the judgment of the multiple principal investigators, may interfere with study participation, assessments, or the ability to follow either the exercise intervention or the health education control.
  23. Use of a permanent or temporary urinary catheter.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    Control Arm

    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.

    Other: Calls and Newsletter

  • Experimental
    Exercise Arm

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

    Behavioral: Exercise

Interventions

  • BehavioralExercise

    An individualized 12-week exercise intervention that will follow American College of Sports Medicine guidelines to ensure a gradual safe increase in frequency and intensity. The exercise goals for participants in the intervention arm are to increase minutes/week of aerobic exercise, build strength and muscle mass, and improve flexibility, core strength, and balance progressively over the course of 12 weeks. The participants are prescribed 3 sessions of aerobic exercise lasting 45-75 minutes each, including warm up and cool down; 2 resistance training sessions per week, and at least 3 flexibility and balance sessions per week. Intervention arm receives the following: Control arm "Successful Aging" newsletter plus additional educational materials related to exercise, heart rate monitor and resistance bands, and two 90-minute sessions and ten 30-minute phone sessions over 12 weeks with an exercise coach (the first two sessions include a resistance training session).

  • OtherCalls and Newsletter

    A 12-week remote health education program developed by the study team to provide a control for the exercise intervention. Participants in this arm will receive a summary of the American College of Sports Medicine guidelines (self-directed and time-based), a twice-monthly "Successful Aging" newsletter with suggestions for health diet, stress reduction, and social engagement, and twice-monthly phone calls to reinforce and discuss topics in the newsletter and to review adverse events and change in medications.

06

What researchers measure

Primary outcomes

  1. Feasibility: proportion randomized

    Proportion of participants randomized of those screened (completed screening call)

    Time frame: 18-24 months

  2. Acceptability: proportion satisfied with exercise intervention

    Proportion of participants who report being satisfied or very satisfied with the exercise intervention at 12 weeks, assessed via digital survey prior to the week 12 visit

    Time frame: 3 months

  3. Fidelity: proportion completing at least 70% of exercise sessions

    Proportion of intervention arm non-drop-outs completing at least 70% of exercise sessions over 12 weeks

    Time frame: 3 months

  4. Safety: number of adverse events

    Number of adverse events, serious adverse events, and unexpected problems (as defined in the Data and Safety Monitoring Plan) by study. Adverse event severity will be defined by the Common Terminology Criteria for Adverse Events (CTCAE) and whether "attributable" to the exercise intervention.

    Time frame: 3 months

  5. Change in International Prostate Symptom Score

    Change in International Prostate Symptom Score (IPSS) from weeks 0 to 12, collected via digital surveys prior to week 0 (baseline) and 12-week visits. Range: 0 (minimum - better) to 35 (maximum - worse)

    Time frame: 3 months

  6. Change in maximum urinary flow rate

    Change in maximum urinary flow rate (Q max) from weeks 0 to 12, measured by trained clinical urology staff using a uroflowmeter in mL per second

    Time frame: 3 months

Secondary outcomes

  1. Acceptability: proportion who would recommend exercise intervention

    Proportion of intervention arm participants who would recommend the exercise intervention to others at 12 weeks, assessed via digital survey prior to the week 12 visit

    Time frame: 3 months

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

    Number of exercise sessions completed over 12 weeks, recorded by the exercise coach based on participant exercise session records. The coach will also report the number of aerobic and resistance exercise sessions completed as prescribed or with greater duration or intensity (e.g., higher heart rate for aerobic sessions or greater sets, reps, and/or weight for resistance sessions) over 12 weeks, based on coaching calls.

    Time frame: 3 months

07

Study locations

2 sites
  • San Francisco VA Medical Center
    San Francisco, California 94121, United States
  • UCSF Health - Mission Bay Campus
    San Francisco, California 94158, United States
08

References and documents

Individual participant data

Plan to share: Yes — As required by NIH rules, data collected as part of the proposed research will be made available to outside investigators, but within the limitations of preserving the anonymity and privacy of individuals. To maintain compliance with HIPAA regulations, our preferred method will be to execute a data sharing agreement with the requestor for a limited use dataset as defined by the US Department of Health and Human Services (DHHS). Although the investigators will require w data, the investigators propose a mechanism for sharing anonymized study data with investigators who do not choose to collaborate with the study.

Supporting information: Analytic code

Time frame: After study completion

Access criteria: Investigators will have to execute a data use agreement before documents with data from the study are sent.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Jul 2026, 30 months.

Of 98 non-industry interventional studies with no phase under Lower Urinary Tract Symptoms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's 30 months is above that.

Counting every sponsor, half of 119 studies reached it within 27 months; a quarter within 11 and three quarters within 54.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 14, 2026: primary completion Apr 2026 → Jul 2026 and completion Apr 2026 → Aug 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2024
First posted
Jan 26, 2024
StartActual
Jan 3, 2024
Primary completionActual
Jul 27, 2026was Apr 2026
CompletionActual
Aug 25, 2026was Apr 2026
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 14, 2026
Primary completion
Apr 1, 2026→Jul 27, 2026 (actual)
Oct 14, 2026
Study completion
Apr 1, 2026→Aug 25, 2026 (actual)
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Recruiting→Completed
    Primary completion Apr 1, 2026→Jul 27, 2026 (now actual)
    Study completion Apr 1, 2026→Aug 25, 2026 (now actual)
    + 4 other changes: index terms, verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06225479
Responsible party
Sponsor
First posted
Jan 26, 2024
Start date
Jan 3, 2024
Primary completion
Jul 27, 2026
Completion
Aug 25, 2026
Last update
Oct 14, 2026

Study contacts

Scott R. Bauer, MD, ScM
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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