Exercise program for older men with urinary issues

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

This study is testing whether a 12-week remote exercise program can help older men with urinary issues feel better and improve their physical health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 60 Years and up
• Sex: Male
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (San Francisco, California and 1 other locations)
• Trial ID: NCT06225479 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial involves 68 physically inactive older men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Participants will engage in a 12-week remote exercise intervention, which includes individualized exercise plans monitored from home, compared to a health education control group. The study aims to assess the feasibility of this exercise intervention and its effects on LUTS severity, physical function, and related biomarkers. The findings could provide significant insights into managing a common condition affecting older men.

Who should consider this trial

Good fit: Ideal candidates are men aged 60 and older who are physically inactive and have moderate-to-severe LUTS attributed to BPH.

Not a fit: Patients who are physically active or do not have LUTS/BPH may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could improve urinary symptoms and overall physical health in older men.

How similar studies have performed: Previous studies have shown promise in using exercise interventions for similar conditions, suggesting potential for success in this approach.

Eligibility criteria

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.
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.

Where this trial is running

San Francisco, California and 1 other locations

• San Francisco VA Medical Center — San Francisco, California, United States (Recruiting)
• UCSF Health - Mission Bay Campus — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Scott R. Bauer, MD, ScM — University of California, San Francisco
• Study coordinator: Scott R. Bauer, MD, ScM

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