RECRUITING

PRescription Exercise for Older Men With Urinary Disease

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia physical fitness endurance training resistance training prostatism male urogenital diseases urinary bladder outlet obstruction skeletal muscle mitochondria

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-03

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06225479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. 11. 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. 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 life expectancy \<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 hemoglobin A1c (\>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.

Inclusion Criteria

Exclusion 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.

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.
11. 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.
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 life expectancy \<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 hemoglobin A1c (\>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.

Contacts and Locations

Study Contact

Scott R. Bauer, MD, ScM

CONTACT

415-221-4810

Scott.Bauer@ucsf.edu

Stacey Kenfield, ScD

CONTACT

415.476.5392

Stacey.Kenfield@ucsf.edu

Principal Investigator

Scott R. Bauer, MD, ScM

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

San Francisco VA Medical Center

San Francisco, California, 94121

United States

UCSF Health - Mission Bay Campus

San Francisco, California, 94158

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Scott R. Bauer, MD, ScM, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2024-01-03

Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia