Search / Trial NCT06225479

PRescription Exercise for Older Men With Urinary Disease

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 24, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Physical Fitness Endurance Training Resistance Training Prostatism Male Urogenital Diseases Urinary Bladder Outlet Obstruction Skeletal Muscle Mitochondria

ClinConnect Summary

This clinical trial is studying the effects of a 12-week remote exercise program for older men who are physically inactive and experiencing lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). The goal is to see if regular exercise can help improve these symptoms compared to a health education program that provides information but does not include exercise. The trial is currently looking for men aged 60 and older who have moderate to severe LUTS and have not been very active in the past year.

Eligible participants should be able to walk 400 meters without assistance and have a smartphone to use an app for monitoring their exercise. If you join the study, you will either follow the exercise program or the health education program for three months. Throughout the trial, your health will be closely monitored, and you will complete questionnaires to help measure any changes in your symptoms. It's important to note that certain medical conditions and medications may prevent participation, so a full list of eligibility criteria will be provided during the screening process.

Gender

MALE

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.

Trial Officials

Scott R. Bauer, MD, ScM

Principal Investigator

University of California, San Francisco

About University Of California, San Francisco

The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.

Locations

San Francisco, California, United States

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0