Lower Urinary Tract SymptomsPROUDNCT06225479
PRescription Exercise for Older Men With Urinary Disease
A study testing Exercise and Calls and Newsletter in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by University of California, San Francisco at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- What is being tested?
- Exercise and Calls and Newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jan 2024to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older.
- Male sex at birth.
- Moderate-to-severe LUTS over the past month (defined as International Prostate Symptom Score [IPSS] >=12).
- 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.
- 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.
- 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.
- Able to speak and complete questionnaires in English.
- Have an iOS or Android smartphone capable of installing the Polar Beat app.
Who cannot join
- Prescribed overactive bladder medications (e.g., anti-muscarinics, beta-3-adrenergic agonists) <3 months before screening.
- 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).
- 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.
- History of BPH procedure or surgery.
- History of overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation).
- History of prostate cancer (treated with surgery or radiation), bladder cancer, other lower urinary tract cancer, pelvic radiation, or active non-urologic cancer treatments.
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- History of urethral strictures.
- History of neurogenic bladder or neurologic conditions causing lower urinary tract dysfunction (e.g., Parkinson's disease, multiple sclerosis, other progressive neurological disease).
- History of recurrent bladder or prostate infections (3 or more infections in the previous 12 months before screening).
- 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.
- Heart attack or myocardial infarction, heart surgery, cardiac catheterization, stroke, transient ischemic attack, 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.
- Bladder or prostate infection <1 months before screening. If infection occurred between 1 to <3 months before screening, can participate with clinician clearance.
- Major surgery <3 months before screening or scheduled in the subsequent 7 months.
- Terminal illness diagnosis with estimated life expectancy <12 months.
- Plan to leave the study area for >28 consecutive days during the subsequent 7 months.
- Participation in formal behavioral LUTS interventions (e.g., pelvic floor physiotherapy) <1 month before screening.
- 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.
- Maximum urinary flow rate <=4 ml/sec OR volume voided during free flow <120ml during screening or the baseline visit.
- Post-void residual >=450ml measured by ultrasound during screening or the baseline visit.
- Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg) or hypotension (systolic blood pressure<100mmHg) measured during baseline visit anthropometric assessments.
- Severe abnormalities on standard clinical labs measured prior to the baseline visit, without clinician clearance, including hemoglobin A1c (>10%) and urinary albumin: creatinine ratio (>300 mg/g).
- 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.
- Use of a permanent or temporary urinary catheter.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco VA Medical Center
San Francisco, California, 94121
UCSF Health - Mission Bay Campus
San Francisco, California, 94158
About this study
Official title: PRescription Exercise for Older Men With Urinary Disease (PROUD) Pilot Study
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).
- Being tested
- Exercise, Calls and Newsletter
- Keywords
- physical fitness, endurance training, resistance training, prostatism, male urogenital diseases, urinary bladder outlet obstruction, skeletal muscle, mitochondria
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Prostatism, Male Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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).
Calls and NewsletterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | 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. Receives: Other: Calls and Newsletter |
| Exercise Arm | Experimental | Participants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: proportion randomized
Proportion of participants randomized of those screened (completed screening call)
Measured: 18-24 months
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
Measured: 3 months
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
Measured: 3 months
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.
Measured: 3 months
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)
Measured: 3 months
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
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start3 Jan 2024
- Primary completion27 Jul 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center 2-arm pilot randomized control trial (RCT) of a 12-week remote exercise intervention and a health education control among 68 physically inactive older men with LUTS/BPH.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, University of California, San Diego, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Scott R. Bauer, MD, ScM, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225479
- Sponsor's protocol ID
- 1R01DK135804-01
- Other IDs
- R01DK135804
- Acronym
- PROUD
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRescription Exercise for Older Men With Urinary Disease (PROUD) Pilot Study
- ClinicalTrials.gov ID
- NCT06225479
- Acronym / sponsor ID
- PROUD / 1R01DK135804-01
- Keywords
- physical fitness, endurance training, resistance training, prostatism, male urogenital diseases, urinary bladder outlet obstruction, skeletal muscle, mitochondria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Berkeley, University of California, San Diego, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center 2-arm pilot randomized control trial (RCT) of a 12-week remote exercise intervention and a health education control among 68 physically inactive older men with LUTS/BPH.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Calls and NewsletterParticipants 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. |
| Exercise Arm | Experimental | Behavioral: ExerciseParticipants in this study arm will receive an individualized 12-week exercise intervention plus a remote health education program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 60 years or older.
- Male sex at birth.
- Moderate-to-severe LUTS over the past month (defined as International Prostate Symptom Score [IPSS] >=12).
- 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.
- 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.
Key exclusion criteria (23 listed)
- Prescribed overactive bladder medications (e.g., anti-muscarinics, beta-3-adrenergic agonists) <3 months before screening.
- 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).
- 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.
- History of BPH procedure or surgery.
- History of overactive bladder procedure (e.g., intravesical Botox, sacral neuromodulation, posterior tibial nerve stimulation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAn 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). | Behavioural | Exercise Arm |
| Calls and NewsletterA 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. | Other | Control Arm |
Primary outcome
Feasibility: proportion randomized
Time frame: 18-24 months
Proportion of participants randomized of those screened (completed screening call)
Acceptability: proportion satisfied with exercise intervention
Time frame: 3 months
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
Fidelity: proportion completing at least 70% of exercise sessions
Time frame: 3 months
Proportion of intervention arm non-drop-outs completing at least 70% of exercise sessions over 12 weeks
Safety: number of adverse events
Time frame: 3 months
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.
Change in International Prostate Symptom Score
Time frame: 3 months
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)
Change in maximum urinary flow rate
Time frame: 3 months
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
2 secondary outcomes
Acceptability: proportion who would recommend exercise intervention
Time frame: 3 months
Fidelity: number of exercise sessions completed for aerobic, resistance, and balance/flexibility exercise
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott R. Bauer, MD, ScM principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Calls and Newsletter in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: proportion randomized (time frame: 18-24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.